title: A Phase 3, Multicenter, 2-Arm Randomized, Open-Label Study of Trastuzumab Deruxtecan in Subjects With HER2-Positive Metastatic and/or Unresectable Gastric or Gastro-Esophageal Junction (GEJ) Adenocarcinoma Subjects Who Have Progressed on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04)

summary: This study will evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with ramucirumab and paclitaxel (Ram + PTX) in participants with HER2-positive gastric or gastro-esophageal junction (GEJ) adenocarcinoma who have progressed on or after a trastuzumab-containing regimen and have not received any additional systemic therapy.

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

lead_sponsor: Daiichi Sankyo, Inc.

sponsor_collaborators:
Daiichi Sankyo, Inc.
AstraZeneca

location_country:
Germany
Ireland
Poland
Argentina
Japan
Brazil
Turkey
Chile
France
Portugal
Hungary
Hong Kong
Ukraine
Romania
Belgium
China
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Uniwersytecki Szpital Kliniczny im.Mikulicza-Radeckiego

location_facility: Institut de Recherche en Cancerologie de Montpellier IRCM

location_facility: Velindre NHS Trust - Velindre Cancer Centre VCC

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Kobe City Medical Center General Hospital

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

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA

location_facility: Zhejiang Medical University - Zhejiang Cancer Hospital

location_facility: University of Oxford, The Churchill Hospital

location_facility: IONC Instituto Oncologico de Cordoba - Fundacion Richardet Longo

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Xinjiang Medical University - Cancer Hospital

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Queens University Belfast - Centre for Cancer Research and Cell Biology CCRCB

location_facility: Institutul Oncologic Prof. Dr. Alexandru Trestiorean Bucuresti IOB

location_facility: PERSONAL - Oncologia de Precisao e Personalizada

location_facility: Xiamen University - The First Affiliated Hospital

location_facility: Private Medical Institution "Euromedservice"

location_facility: The Sixth Affiliated Hospital of Sun Yat-Sen University

location_facility: Chonnam National University Hwasun Hospital

location_facility: Fujian Medical University - Fujian Provincial Cancer Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire CHU de Rennes - Hopital de Pontchaillou

location_facility: Istituto Europeo di Oncologia S.r.L Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini

location_facility: Fudan University - Shanghai Cancer Center

location_facility: National Taiwan University Hospital NTUH

location_facility: Chonbuk National University Hospital - Jeonbuk Regional Cancer Center

location_facility: SBIH Chelyabinsk Regional Clinical Centre of Oncology and Nuclear Medicine

location_facility: Instituto Portugues De Oncologia Do Porto Francisco Gentil, E.P.E.

location_facility: The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH) - Vascular and Interventional Radiology Foundation (VIRF) Clinical Science Centre


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

acronym: InMIND

summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

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

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

lead_sponsor: Incyte Corporation

location_country:
Finland
Germany
Ireland
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Ukraine
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

location_facility: Goetalandsregionen - Uddevalla Sjukhus Us

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital of the University of Occupation and Environmental Health

location_facility: University Clinic Giessen Und Marburg Ukgm

location_facility: Chru Hopitaux de Tours Hospital Bretonneau

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Uo Ematologia Univ - Aoup Santa Chiara Pisa

location_facility: Medizinische Fakultaet Mannheim Der Universitaet Heidelberg

location_facility: "Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic

location_facility: The Center For Cancer and Blood Disorders

location_facility: National Cheng Kung University (Ncku) Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Queen Elizabeth Ii Health Sciences Centre

location_facility: Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Severance Hospital Yonsei University Health System

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna

location_facility: Des Moines Oncology Research Association

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Kobe City Medical Center General Hospital

location_facility: National Cancer Institute of Ministry of Health

location_facility: University Hospital of Basel Department of Oncology

location_facility: McGill University Jewish General Hospital

location_facility: Shamir Medical Center Formerly Assaf Harofeh Medical Center

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Keimyung University Dongsan Medical Center

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: John Muir Health Clinical Research Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Universitetssykehuset I Trondheim - St. Olavs Hospital

location_facility: Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)

location_facility: Hospital General Unviersitario de Alicante

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Universitair Ziekenhuis Antwerpen, Dienst Hematologie

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: University Hospital of West Attica - Attikon

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Institutional Review Board Taipei Veterans General Hospital

location_facility: Communal Non-Profit Enterprise Regional Center of Oncology

location_facility: Wollongong Hospital - Illawarra Regional Hospital

location_facility: Charleston Hematology Oncology Associates

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Uniwersytet Medyczny W Lodzi - Klinika Hematologii

location_facility: Pusan National University Yangsan Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

location_facility: Daegu Catholic University Medical Center

location_facility: Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

location_facility: University Hospitals Birmingham Nhs Foundation Trust

location_facility: Ausl Di Placenza Ospedale Guglielmo Da Saliceto

location_facility: The Catholic University of Korea Yeoido St.Mary'S Hospital

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Hospital Universitario Virgen del Rocio Sevilla

location_facility: Oncological Institute of Southern Switzerland

location_facility: Consorci Hospitalari Parc Tauli de Sabadell

location_facility: Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center

location_facility: Hospital Saint-Louis Service Oncologie Medicale

location_facility: University of Maryland-Greenebaum Cancer Center

location_facility: University of Washington-Seattle Cancer Care Alliance

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

location_facility: Klinik Fur Innere Medizin Hamatologie and Onkologie

location_facility: Uppsala Universitet - Akademiska Sjukhuset

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Ireland
Poland
Argentina
Japan
Brazil
Turkey
Czechia
Canada
France
Colombia
Hong Kong
United States
Ukraine
Belgium
China
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Friendship Hospital, Capital Medical University

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico

location_facility: Institut Mutualiste Montsouris; Oncologie

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Fujian Medical University Union Hospital

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: CUAN Hospital; Centro de Urologia Avnazada del Noreste

location_facility: Hospital Universitari Vall d'Hebron; Oncology

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

location_facility: St James Hospital; Dept of Oncology/Hematology

location_facility: Alexandras General Hospital of Athens; Oncology Department

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

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: FSI Russian Centre of Radiology and Surgical Technologies

location_facility: Oncocentro Serviços Medicos E Hospitalares Ltda

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Southampton University Hospitals NHS Trust

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: *X*Fundação Pio XII Hospital de Câncer de Barretos

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

location_facility: The 2nd Hospital of Tianjin Medical University; Department of Urology

location_facility: AZ.Osp S. Orsola ? Malpighi-Reparto di Oncologia Medica

location_facility: Queen Mary Hospital; Dept. Of Haematology & Oncology

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

location_facility: University Hospital of Patras Medical Oncology

location_facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

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

location_facility: Saitama Medical University International Medical Center

location_facility: FSBSI ?N. N. Blokhin Russian Cancer Research Center?

location_facility: St-Petersburg Regional Oncology Dispensary; Oncology

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Szpital Grochowski im. dr med. Rafa?a Masztaka Sp. z o.o.

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

location_facility: FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER

location_facility: Complejo Hospitalario Universitario Insular?Materno Infantil; Servicio de Oncologia

location_facility: Fakultni Thomayerova nemocnice; Onkologicka klinika 1. LF UK a FTN

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: University College London NHS Foundation Trust

location_facility: Instituto Cancerologia Medellin; Clinica Las Americas

location_facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

location_facility: Universitätsklinikum Jena, Urologische Klinik und Poliklinik

location_facility: Hospital Alemao Oswaldo Cruz; Pesquisa Clinica

location_facility: Dolno?l?skie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: National Cancer Centre; Medical Oncology

location_facility: Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

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


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)

summary: This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

ReferenceType: derived

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: open (via page says license)

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Janjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10.

oa_colors: green hybrid

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

version: acceptedVersion

repository_institution: Yonsei University Medical Library - YUHSpace

version: submittedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

ReferenceCitation: Cowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18. No abstract available.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

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

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Chile
Canada
France
Hungary
Denmark
United States
Belgium
Peru
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis

summary:
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.

The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival and it is safe and well tolerated in patients with stage IIIa AL amyloidosis.

ipd_sharing_description: Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.

lead_sponsor: Alexion Pharmaceuticals, Inc.

location_country:
Germany
Poland
Australia
Brazil
Japan
Czechia
Canada
France
United States
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility:
Clinical Trial Site
Clinical Trial site


acronym: A study to assess the efficacy and safety of nemolizumab in subjects with prurigo nodularis

lead_sponsor: Galderma R&D

summary: The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.

status: Completed

title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis

source: euctr

study_completion_date_type: Actual

location_country:
Poland
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Canada
France

status_simplified: Completed


title: A Phase 2, Randomized Study of Neoadjuvant Nivolumab Plus Ipilimumab Followed by Adjuvant Nivolumab or Neoadjuvant Nivolumab Plus Ipilimumab Followed by Either Adjuvant Nivolumab or Postsurgical Observation Depending on Pathologic Response Compared With Adjuvant Nivolumab in Treatment-Naive Patients With Resectable Clinically Detectable Stage III Melanoma

acronym: CheckMate 7UA

summary: The purpose of this study is to evaluate the role of neoadjuvant immunotherapy and to demonstrate high pathologic complete response (pCR) and near pCR rates in melanoma participants with clinically detectable nodal disease and a high risk of recurrence. Neoadjuvant immunotherapy aims to enhance the systemic T-cell response to tumor antigens while detectable tumor is still present, inducing a stronger and broader tumor-specific immune response. Of the neoadjuvant approaches studied within melanoma, the neoadjuvant combination of nivolumab and ipilimumab has demonstrated high pCR and near pCR rates that may translate to prolonged clinical benefit.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

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

intervention_type: Biological

status_simplified: Unknown


summary: This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.

title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Slovakia
Hungary
Hong Kong
United States
India
Belgium
China
Peru
Philippines
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


type: Other Identifier

title: A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis

acronym: GEMINI 2

summary:
Primary Objective:

To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS

Secondary Objective:

To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168

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
Argentina
Brazil
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Portugal
Slovakia
Hungary
Switzerland
United States
Latvia
Ukraine
India
Belgium
Puerto Rico
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: Prairie Education and Research Cooperative-Site Number:8400071

location_facility: Multiple Sclerosis Center of California-Site Number:8400135

location_facility: Infinity Clinical Research-Site Number:8400008

location_facility: Center for Neurology and Spine-Site Number:8400089

location_facility: Advanced Neuroscience Center-Site Number:8400035

location_facility: Saint Luke's Hospital-Site Number:8400153

location_facility: University of Kentucky-Site Number:8400106

location_facility: Dayton Center for Neurological Disorders-Site Number:8400081

location_facility: Fort Wayne Neurological Center-Site Number:8400039

location_facility: International Neurorehabilitation Institute-Site Number:8400034

location_facility: Neurology Center of San Antonio-Site Number:8400036

location_facility: Mountain Neurological Research Center, Inc.-Site Number:8400128

location_facility: Meridian Clinical Research-Site Number:8400003

location_facility: Meridian Clinical Research, LLC-Site Number:8400005

location_facility: Sanford Brain & Spine Center-Site Number:8400126

location_facility: Jefferson Neurology Associates-Site Number:8400016

location_facility: West Omaha Family Physicians-Site Number:8400139

location_facility: Advanced Neurosciences Research-Site Number:8400025

location_facility: University of Florida Health-Site Number:8400159

location_facility: South Florida Neurology Associates-Site Number:8400029

location_facility: Hackensack University Hospital-Site Number:8400047

location_facility: Wayne State University-Site Number:8400046

location_facility: CHI Saint Joseph Medical Group Neurology-Site Number:8400110

location_facility: Neurology Associates, PA-Site Number:8400004

location_facility: The NeuroMedical Center-Site Number:8400057

location_facility: South Shore Neurologic Associates-Site Number:8400100

location_facility: Wheaton Franciscan Healthcare-Site Number:8400022

location_facility: Minneapolis Clinic of Neurology-Site Number:8400051

location_facility: Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151

location_facility: Arcadia Neurology Center-Site Number:8400070

location_facility: Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120

location_facility: University of New Mexico-Site Number:8400032

location_facility: University of South Florida-Site Number:8400006

location_facility: North Central Neurology Associates, PC-Site Number:8400009

location_facility: University Of Nebraska-Site Number:8400129

location_facility: Consultants In Neurology-Site Number:8400011

location_facility: Mt Olympus Medical Research-Site Number:8400163

location_facility: Norton Neurology MS Services-Site Number:8400127

location_facility: Sibyl Wray, MD, Neurology, PC-Site Number:8400007


title: A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

acronym: OSCAR

summary: OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Argentina
Japan
Brazil
Chile
Canada
France
Colombia
United States
India
Belgium
Peru
Italy
United Kingdom
Netherlands
Mexico
Spain
South Africa
Russian Federation


title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)

acronym: CheckMate 74W

summary: The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.

location_country:
Germany
Poland
Australia
Japan
Czechia
Canada
France
Hong Kong
United States
Belgium
China
Puerto Rico
Italy
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility:
Local Institution - 0141
Local Institution - 0102
Local Institution - 0021
Local Institution - 0011
Local Institution - 0009
Local Institution - 0071
Local Institution - 0077
Local Institution - 0035
Local Institution - 0209
Local Institution - 0044
Local Institution - 0164
Local Institution - 0039
Local Institution - 0101
Local Institution - 0005
Local Institution - 0014
Local Institution - 0148
Local Institution - 0016
Local Institution - 0076
Local Institution
Local Institution - 0120
Local Institution - 0078
Local Institution - 0026
Local Institution - 0115
Local Institution - 0097
Local Institution - 0099
Local Institution - 0087
Local Institution - 0046
Local Institution - 0128
Local Institution - 0116
Local Institution - 0132
Local Institution - 0070
Local Institution - 0037
Local Institution - 0023
Local Institution - 0139
Local Institution - 0176
Local Institution - 0109
Local Institution - 0053
Local Institution - 0025
Local Institution - 0131
Local Institution - 0121
Local Institution - 0196
Local Institution - 0119
Local Institution - 0082
Local Institution - 0117
Local Institution - 0161
Local Institution - 0136
Local Institution - 0186
Local Institution - 0064
Local Institution - 0061
Local Institution - 0052
Local Institution - 0151
Local Institution - 0118
Norton Cancer Institute Audubon
Local Institution - 0108
Local Institution - 0114
Local Institution - 0047
Local Institution - 0049
Local Institution - 0004
Local Institution - 0050
Local Institution - 0048
Local Institution - 0010
Local Institution - 0089
Local Institution - 0122
Local Institution - 0030
Local Institution - 0057
Local Institution - 0029
Local Institution - 0084
Local Institution - 0018
Local Institution - 0189
Local Institution - 0092
Local Institution - 0113
Local Institution - 0015
Local Institution - 0055
Local Institution - 0002
Local Institution - 0135
Local Institution - 0184
Local Institution - 0125
Local Institution - 0012
Local Institution - 0160
Local Institution - 0020
Local Institution - 0001
Local Institution - 0094
Local Institution - 0013
Local Institution - 0045
Local Institution - 0127
Local Institution - 0123
Local Institution - 0093
Local Institution - 0183


title: The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

acronym: BURAN

summary: The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

ipd_sharing: No

lead_sponsor: Adlai Nortye Biopharma Co., Ltd.

location_country:
Germany
Italy
Poland
Hungary
Argentina
Hong Kong
Australia
Japan
United Kingdom
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: The Fifth Affiliated Hospital of Sun Yat-sen University

location_facility: Vall dHebron Institute of Oncology (VHIO)

location_facility: Hospital Clinico Universitario Valencia - INCLIVA

location_facility: Fundacion CORI para la Investigacion y Prevencion del Cáncer

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: National University Corporation Tohoku University, Tohoku University Hospital

location_facility: Azienda Ospedaliera San Paolo Polo Universitario

location_facility: Xiangya Hospital Central South University

location_facility: Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone" U.O.C. Oncologia Medica

location_facility: University of Pecs Department of Oncotherapy

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

location_facility: Fundacion Cenit para la Investigacion en Neurociencias

location_facility: Hospital Duran i Reynals - Institut Catala dOncologia ICO

location_facility: Azienda Ospedaliero Universitaria Careggi - Firenze

location_facility: Centre hospitalier Universitaire de Bordeaux

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Instituto de Investigaciones Metabólicas (IDIM) // Instituto de Investigaciones Metabólicas S.A.

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

location_facility: Affiliated Cancer Hospital of Chongqing University

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

location_facility: UNIVERSITÄTSMEDIZIN Mainz III. Klinik/Poliklinik

location_facility: The Royal Marsden NHS Foundation Trust - Sutton

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Saitama Medical University International Medical Center

location_facility: Cancer Hospital affiliated to Guangxi Medical University

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital General Universitario Gregorio Maran

location_facility: ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Valme Hospital Medical Oncology Department

location_facility: Washington University School of Medicine

location_facility: Affiliated Cancer Hospital of Guangzhou Medical University

location_facility: Seoul National University Bundang Hospital

location_facility: Centro para la Atencion Integral del Paciente Oncologico - CAIPO

location_facility: Hope Cancer Center, UT Health East Texas

location_facility: Hospital Universitario Santiago de Compostela

location_facility: IONC SRL- Instituto Oncológico de Córdoba

location_facility: Centro de Investigacion Pergamino SA - Clinica Pergamino S.A.

location_facility: Azienda Ospedaliera Universitaria S.Orsola-Malpighi

location_facility: Institut regional du Cancer de Montpellier

location_facility: AOU San Giovanni di Dio e Ruggi D'Aragona, Università degli Studi di Salerno

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: A.O.U. "Maggiore della Carita"- S.C.D.U Oncologiac

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: HNO-Klinik des Universitats-Klinikums Giessen

location_facility: Fundacion Oncologico de Galicia Jos Antonio Quiroga y Pieyro


acronym: PEVENAZA

lead_sponsor: Takeda

summary:
The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy.

Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin).

Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

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

location_facility: University Hospitals Cleveland Medical Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: AdventHealth (Florida Hospital) - Transplant Institute

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Institut dHematologie de Basse Normandie

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

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

location_facility: University of Miami Miller School of Medicine

title: A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

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:
Italy
Poland
United States
Canada
France


acronym: DOR/ISL Blinded Label Switch

lead_sponsor: Merck Sharp & Dohme LLC

summary: This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48. Participants who benefit from their assigned intervention (as determined by investigator) will be able to continue treatment through a 24-week study extension.

location_facility: A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507)

location_facility: Hospital Universitari de Bellvitge ( Site 3612)

location_facility: CAIMED Center - Ponce School of Medicine ( Site 2903)

location_facility: MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002)

location_facility: Prahran Market Clinic (PMC) ( Site 3806)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 7203)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 2700)

location_facility: Hospital 12 de Octubre de Madrid ( Site 3605)

location_facility: Zuckerberg San Francisco General Hospital UCSF ( Site 2743)

location_facility: Universitaetsklinikum Essen ( Site 3007)

location_facility: Chatham County Health Department ( Site 2731)

location_facility: Universita' Vita Salute. Ospedale San Raffaele ( Site 3502)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 3601)

location_facility: Social Medical Center - Otto Wagner Hospital ( Site 3404)

location_facility: ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003)

location_facility: Midway Immunology and Research ( Site 2759)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501)

location_facility: Centre Hospitalier Regional du Orleans ( Site 3108)

location_facility: Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812)

location_facility: Hope Clinical Research, Inc. ( Site 2902)

location_facility: CHU de Nancy Hopital Brabois Adultes ( Site 3128)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 3603)

location_facility: Taylor Square Private Clinic ( Site 3804)

location_facility: Hospital Universitari Vall d Hebron ( Site 3602)

location_facility: Holdsworth House Medical Practice - Brisbane ( Site 3810)

location_facility: Triple O Research Institute, P.A. ( Site 2755)

location_facility: DCOL Center for Clinical Research ( Site 2769)

location_facility: Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400)

location_facility: The Crofoot Research Center, Inc. ( Site 2715)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 7201)

location_facility: Hospital Universitario La Paz ( Site 3604)

location_facility: Azienda Ospedaliera San Paolo ( Site 3503)

location_facility: ICH Study Center GmbH & Co.KG ( Site 3009)

location_facility: National Hospital Organization Osaka National Hospital ( Site 7202)

location_facility: Hospital Universitario Infanta Leonor ( Site 3606)

location_facility: CHU de Nice Hopital Archet 1 ( Site 3103)

location_facility: Infectious Disease Specialists Of Atlanta PC ( Site 2719)

location_facility: Clinical Research Puerto Rico Inc ( Site 2900)

location_facility: North Texas ID Consultants, PA ( Site 2707)

location_facility: Medizinische Hochschule Hannover ( Site 3012)

location_facility: Kaiser Permanente Los Angeles Medical Center ( Site 2775)

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 3121)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 3500)

location_facility: Clinique de Medecine Urbaine du Quartier Latin ( Site 2804)

location_facility: Hospital Universitario Ramon y Cajal ( Site 3611)

location_facility: Helsinki University Hospital ( Site 3200)

location_facility: Vancouver ID Research and Care Centre Society ( Site 2800)

location_facility: Hennepin County Medical Center ( Site 2733)

location_facility: Klinikum rechts der Isar der Technischen Universitat ( Site 3005)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 3609)

location_facility: Holdsworth House Medical Practice ( Site 3800)

location_facility: University of California, Davis, Division of ID Research ( Site 2702)

location_facility: Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010)

location_facility: Centre Hospitalier de Tourcoing ( Site 3100)

location_facility: Hospital Clinic i Provincial ( Site 3600)

title: A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)

location_country:
Finland
Germany
Italy
Australia
Japan
Austria
United States
Spain
Canada
Puerto Rico
France


lead_sponsor: Loxo Oncology, Inc.

summary: The reason for this study is to see if the study drug selpercatinib is safe and more effective compared to a standard treatment in participants with rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) that cannot be removed by surgery or has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

ReferenceCitation: Wirth LJ, Brose MS, Elisei R, Capdevila J, Hoff AO, Hu MI, Tahara M, Robinson B, Gao M, Xia M, Maeda P, Sherman E. LIBRETTO-531: a phase III study of selpercatinib in multikinase inhibitor-naive RET-mutant medullary thyroid cancer. Future Oncol. 2022 Sep;18(28):3143-3150. doi: 10.2217/fon-2022-0657. Epub 2022 Aug 15.

ReferenceCitation: Jaber T, Dadu R, Hu MI. Medullary thyroid carcinoma. Curr Opin Endocrinol Diabetes Obes. 2021 Oct 1;28(5):540-546. doi: 10.1097/MED.0000000000000662.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Klinikum der Universität München Großhadern

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut Català d'Oncologia (ICO) - Girona

location_facility: Icesp - Instituto Do Câncer Do Estado de São Paulo

location_facility: Grupo COI - Clínicas Oncológicas Integradas

location_facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Beijing Tongren Hospital affiliated to Capital Medical University

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: First Affiliated Hospital of Kunming Medical University

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

location_facility: Grant Medical Foundation - Ruby Hall Clinic

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: University of Wisconsin Hospitals and Clinics

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

location_facility: Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

location_facility: Providence Cancer Center Oncology Hematology Care

location_facility: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Post Graduate Institute of Medical Education & Research (PGIMER)

location_facility: Universitätsmedizin Johannes Gutenberg Universität Mainz

location_facility: Regional Cancer Centre - Thiruvananthapuram

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach

location_facility: Seoul National University Bundang Hospital

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)

location_facility: A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Harbin Medical University Cancer Hospital

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hämato-Onkologie Hamburg, Prof. Laack und Partner

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

location_facility: University General Hospital of Heraklion

location_facility: University of California Davis (UC Davis) Comprehensive Cancer Center

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

location_facility: Endocrinology Research Center of Rosmedtechnologies

location_facility: The First Affiliated Hospital Of Fujian Medical University

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Centre Hospitalier Universitaire d'Angers

title: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531)

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
Poland
Australia
Brazil
Japan
Czechia
Canada
France
United States
India
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


summary:
The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:

Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS).
Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS).

As of Amendment 3, study enrollment is being discontinued. Participants who are receiving benefit from the study intervention may continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.

location_facility: Massachusetts General Hospital ( Site 0155)

location_facility: National Cheng Kung University Hospital ( Site 2303)

location_facility: Orszagos Onkologiai Intezet ( Site 1602)

location_facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 0707)

location_facility: St Vincents University Hospital ( Site 0900)

location_facility: Kyungpook National University Chilgok Hospital ( Site 2402)

location_facility: Hospital General Arnau de Vilanova de Valencia ( Site 0706)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1512)

location_facility: Gynaekologisches Zentrum-Schwerpunkt Gyn. Onkologie ( Site 1205)

location_facility: University of Miami Sylvester CC ( Site 0146)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0601)

location_facility: Hospital Universitario Reina Sofia ( Site 0705)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0160)

location_facility: Pleszewskie Centrum Medyczne w Pleszewie Sp. z o.o. ( Site 1909)

location_facility: Sana Klinikum Offenbach Klinik fuer Gynakologie und Geburtshilfe ( Site 1206)

location_facility: The Christie NHS Foundation Trust ( Site 0914)

location_facility: Texas Oncology-New Braunfels ( Site 0168)

location_facility: Universitaetsklinikum Mannheim GmbH ( Site 1213)

location_facility: Seoul National University Hospital ( Site 2403)

location_facility: Fundacion Arturo Lopez Perez ( Site 0500)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 1009)

location_facility: John Wayne Cancer Institute ( Site 0111)

location_facility: Texas Oncology-San Antonio Northeast ( Site 0165)

location_facility: Klinik und Poliklinik fuer Frauenheilkunde und Geburtshilfe ( Site 1200)

location_facility: Hospital Clinic I Provincial de Barcelona ( Site 0702)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2300)

location_facility: St. Joseph Heritage Healthcare ( Site 0104)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0501)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 0158)

location_facility: Fukushima Medical University Hospital ( Site 2201)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 1605)

location_facility: Gachon University Gil Medical Center ( Site 2408)

location_facility: Blackpool Victoria Hospital ( Site 0921)

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

location_facility: Centro Investigación del Cáncer James Lind ( Site 0510)

location_facility: Gynaekologisch-onkologische Praxis Hannover ( Site 1207)

location_facility: Mercy Clinic Oncology and Hematology ( Site 0110)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 1517)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1912)

location_facility: Princess Margaret Cancer Centre ( Site 0005)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 1001)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1604)

location_facility: Texas Oncology - San Antonio Stone Oak ( Site 0166)

location_facility: Virginia Oncology Associates ( Site 0153)

location_facility: CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 1007)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1601)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1600)

location_facility: CI Krivorizhskiy oncology dispensery ( Site 1504)

location_facility: Aichi Cancer Center Hospital ( Site 2202)

location_facility: Universitaetsklinikum AoeR Duesseldorf ( Site 1210)

location_facility: SI-Zaytsev institute of general and urgent surgery-NAMS ( Site 1518)

location_facility: Hyogo College of Medicine Hospital ( Site 2203)

location_facility: Virginia Oncology Associates ( Site 0164)

location_facility: Zhytomyr Regional Oncology Center ( Site 1515)

location_facility: Georgia Cancer Center at Augusta University ( Site 0129)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1608)

location_facility: YVMH dba Virginia Mason Memorial/North Star Lodge Cancer Center ( Site 0128)

location_facility: Universitaetsklinikum Erlangen ( Site 1201)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2204)

location_facility: Hospital Universitari Vall d Hebron ( Site 0701)

location_facility: China Medical University Hospital ( Site 2302)

location_facility: McGill University Health Centre ( Site 0002)

location_facility: Virginia Oncology Associates ( Site 0163)

location_facility: CSSS de Laval- Hopital de la Cite de la Sante ( Site 0011)

location_facility: Medical Centre LLC Oncolife ( Site 1510)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 1520)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0161)

location_facility: Seoul National University Bundang Hospital ( Site 2409)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1203)

location_facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1508)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0138)

location_facility: Hochwaldkrankenhaus Bad Nauheim ( Site 1211)

location_facility: The Center For Cancer And Blood Disorders ( Site 0151)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 1502)

location_facility: Clinica Universitaria Navarra - Madrid ( Site 0700)

location_facility: Severance Hospital Yonsei University Health System ( Site 2401)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 22

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1913)

location_facility: Virginia Piper Cancer Institute ( Site 0157)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1506)

location_facility: Organizacion Clinica Bonnadona-Prevenir S.A.S. ( Site 0609)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0003)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 0156)

location_facility: Regionalny Szpital Specjalistyczny Latawiec ( Site 1917)

location_facility: Medical Centre Consilium Medical ( Site 1514)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 2304)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 1607)

title: An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK-009)

location_country:
Germany
Ireland
Poland
Colombia
Hungary
United Kingdom
Japan
United States
Korea, Republic of
Spain
Chile
Taiwan
Canada
Ukraine
France


lead_sponsor: Eisai Inc.

summary: This Is a Multicenter, Randomized, Open-Label, Parallel-Group, Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination with Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents, and Young Adults with Relapsed or Refractory Osteosarcoma.

ReferenceCitation: Gaspar N, Venkatramani R, Hecker-Nolting S, Melcon SG, Locatelli F, Bautista F, Longhi A, Lervat C, Entz-Werle N, Casanova M, Aerts I, Strauss SJ, Thebaud E, Morland B, Nieto AC, Marec-Berard P, Gambart M, Rossig C, Okpara CE, He C, Dutta L, Campbell-Hewson Q. Lenvatinib with etoposide plus ifosfamide in patients with refractory or relapsed osteosarcoma (ITCC-050): a multicentre, open-label, multicohort, phase 1/2 study. Lancet Oncol. 2021 Sep;22(9):1312-1321. doi: 10.1016/S1470-2045(21)00387-9. Epub 2021 Aug 17.

oa_colors: green other

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

publisher_dissemination: Elsevier

ReferenceCitation: Gaspar N, Campbell-Hewson Q, Huang J, Okpara CE, Bautista F. OLIE, ITCC-082: a Phase II trial of lenvatinib plus ifosfamide and etoposide in relapsed/refractory osteosarcoma. Future Oncol. 2021 Nov;17(32):4249-4261. doi: 10.2217/fon-2021-0743. Epub 2021 Aug 12.

oa_host_type: publisher

sponsor_collaborators:
Eisai Inc.
Merck Sharp & Dohme LLC

location_facility: Princess Maxima Center for Pediatric Oncology

location_facility: Severance Hospital Yonsei University Health System

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Schneider Children's Medical Center of Israel

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Hospital Infantil Universitario Niño Jesus

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Drottning Silvias Barn Och Ungdomssjukhus

location_facility: University of Mississippi Medical Center

title: A Multicenter, Open-label, Randomized Phase 2 Study to Compare the Efficacy and Safety of Lenvatinib in Combination With Ifosfamide and Etoposide Versus Ifosfamide and Etoposide in Children, Adolescents and Young Adults With Relapsed or Refractory Osteosarcoma (OLIE)

ipd_sharing_description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

location_country:
Finland
Ireland
New Zealand
Australia
Czechia
Canada
France
Hong Kong
Switzerland
United States
Belgium
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel


title: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

acronym: CheckMate 7FL

summary: A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Hong Kong
Denmark
Switzerland
United States
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Azienda Ospedaliero Universitaria Federico II di Napoli

location_facility: Fondazione Irccs - Policlinico San Matteo

location_facility: Istituto Nazionale Tumori Fondazione Pascale


acronym: QUASAR

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

location_facility: Tianjin Medical University General Hospital

location_facility: National Hospital Organization Kochi National Hospital

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika

location_facility: Sumy State University, Sumy Regional Clinical Hospital

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Tongji Hospital, Tongji Medical College of HUST

location_facility: GIRI Gastrointestinal Research Institute

location_facility: University of North Carolina at Chapel Hill

location_facility: The Sixth Affiliated Hospital Sun Yat sen University

location_facility: Gastroenterology Associates of Tidewater

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Japan Community Health Care Organization Saitama Medical Center

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: UF Health Jacksonville Gastroenterology Emerson

location_facility: NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Mersin University Medical Faculty Hospital

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: The second Xiangya Hospital of Central South University

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: Shengjing Hospital of China Medical University

location_facility: SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Gastroenterology Department GASTROMART s.r.o.

location_facility: Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Accout Center, s.r.o., Gastroenterologická ambulancia

location_facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Gastroenterologie, s.r.o., Hradec Kralove

location_facility: All-Russian Center of Emergency and Radiation Medicine MCRS

location_facility: The First Affiliated Hospital of NanChang University

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

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

location_facility: Gastroenterology Associates of Orangeburg, SC

location_facility: NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'

location_facility: Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'

location_facility: Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Capital Medical University, Beijing Friendship Hospital

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy

location_facility: Hospital de Alta Complejidad en Red 'El Cruce'

location_facility: Toronto Immune & Digestive Health Institute Inc.

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: The First Affiliated Hospital Zhejiang University College of Medicine

location_facility: Sai Clinic, Gastrointestinal and Protology Divisions

location_facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

location_facility: Semmelweis Egyetem, Ii. Belgyogyaszati Klinika

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

location_facility: Universitaetsklinikum Salzburg - Landeskrankenhaus

location_facility: Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro

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

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'

location_facility: First Affiliated Hospital of Gannan Medical University

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

location_facility: CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao

location_facility: The first affiliated hospital of suzhou University

location_facility: First Affiliated Hospital of Kunming Medical Unversity

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: West China Hospital of Sichuan University

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Hospital General de Agudos José Maria Ramos Mejía

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov

location_facility: Harmony Medical Research Institute, Inc.

location_facility: The 1st affiliated hospital of Anhui Medical University

location_facility: Fundacao Universidade Federal do Piaui - Universidade Federal do Piaui

location_facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

location_facility: The Second Affiliated Hospital of Zhejiang University

location_facility: Gastroenterolgy Associates of Central GA

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Hirosaki General Medical Center

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

location_facility: The Second Hospital Affiliated To Suzhou University

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: Universitaetsklinikum Charite, Campus Virchow Klinikum

location_facility: Northshore Gastroenterology Research, LLC

location_facility: The Second Hospital To Dalian Medical University

location_facility: University of Florida Health Jacksonville

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont

location_facility: Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways

location_facility: Universidade Federal do Rio de Janeiro - Faculdade de Medicina

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

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

location_country:
Germany
Ireland
Poland
Taiwan
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
Serbia
France
Portugal
Slovakia
Hungary
United States
Latvia
Ukraine
Belgium
China
Malaysia
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Jordan
Bulgaria
Russian Federation
Israel


title: A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

summary: Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

location_country:
Germany
Poland
New Zealand
Australia
Czechia
Canada
France
Lithuania
Hungary
United States
Latvia
Belgium
Estonia
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Bulgaria
Georgia

location_facility:
Galderma Investigational Site 8336
Galderma Investigational Site 8142
Galderma Investigational Site 8656
Galderma Investigational Site 8711
Galderma Investigational Site 8825
Galderma Investigational Site 8791
Galderma Investigational Site 8729
Galderma Investigational Site 6037
Galderma Investigational Site 8329
Galderma Investigational Site 6108
Galderma Investigational Site 8133
Galderma Investigational Site 5458
Galderma Investigational Site 6194
Galderma Investigational Site 6059
Galderma Investigational Site 8856
Galderma Investigational Site 8667
Galderma Investigational Site 6132
Galderma Investigational Site 8521
Galderma Investigational Site 6235
Galderma Investigational Site 6088
Galderma Investigational Site 8298
Galderma Investigational Site 6185
Galderma Investigational Site 6126
Galderma Investigational Site 8242
Galderma Investigational Site 8743
Galderma Investigational Site 8745
Galderma Investigational Site 6122
Galderma Investigational Site 5659
Galderma Investigational Site 6161
Galderma Investigational Site 8085
Galderma Investigational Site 6250
Galderma Investigational Site 8748
Galderma Investigational Site 6060
Galderma Investigational Site 6084
Galderma Investigational Site 6227
Galderma Investigational Site 8636
Galderma Investigational Site 5021
Galderma Investigational Site 8904
Galderma Investigational Site 6096
Galderma Investigational Site 5140
Galderma Investigational Site 8536
Galderma Investigational Site 8739
Galderma Investigational Site 6106
Galderma Investigational Site 8866
Galderma Investigational Site 6121
Galderma Investigational Site 6094
Galderma Investigational Site 6153
Galderma Investigational Site 6062
Galderma Investigational Site 8833
Galderma Investigational Site 8805
Galderma Investigational Site 8780
Galderma Investigational Site 6041
Galderma Investigational Site 6051
Galderma Investigational Site 6055
Galderma Investigational Site 6085
Galderma Investigational Site 8738
Galderma Investigational Site 6177
Galderma Investigational Site 8870
Galderma Investigational Site 6056
Galderma Investigational Site 8724
Galderma Investigational Site 8804
Galderma Investigational Site 6025
Galderma Investigational Site 6069
Galderma Investigational Site 6228
Galderma Investigational Site 6131
Galderma Investigational Site 6152
Galderma Investigational Site 6105
Galderma Investigational Site 6061
Galderma Investigational Site 8674
Galderma Investigational Site 8586
Galderma Investigational Site 6057
Galderma Investigational Site 8670
Galderma Investigational Site 6103
Galderma Investigational Site 8702
Galderma Investigational Site 6112
Galderma Investigational Site 8224
Galderma Investigational Site 8203
Galderma Investigational Site 6099
Galderma Investigational Site 8906
Galderma Investigational Site 6109
Galderma Investigational Site 6095
Galderma Investigational Site 6110
Galderma Investigational Site 8850
Galderma Investigational Site 8713
Galderma Investigational Site 6036
Galderma Investigational Site 8777
Galderma Investigational Site 6216
Galderma Investigational Site 8683
Galderma Investigational Site 5773
Galderma Investigational Site 8721
Galderma Investigational Site 8686
Galderma Investigational Site 6223
Galderma Investigational Site 6058
Galderma Investigational Site 8737
Galderma Investigational Site 6169
Galderma Investigational Site 6026
Galderma Investigational Site 5580
Galderma Investigational Site 8749
Galderma Investigational Site 6164
Galderma Investigational Site 6244
Galderma Investigational Site 8888
Galderma Investigational Site 5482
Galderma Investigational Site 8817
Galderma Investigational Site 5551
Galderma Investigational Site 8826
Galderma Investigational Site 6203
Galderma Investigational Site 6134
Galderma Investigational Site 6086
Galderma Investigational Site 5570
Galderma Investigational Site 8862
Galderma Investigational Site 6205
Galderma Investigational Site 8664
Galderma Investigational Site 5638
Galderma Investigational Site 6167
Galderma Investigational Site 8820
Galderma Investigational Site 5513
Galderma Investigational Site 8391
Galderma Investigational Site 8226
Galderma Investigational Site 6230
Galderma Investigational Site 6113
Galderma Investigational Site 6145
Galderma Investigational Site 8155
Galderma Investigational Site 8161
Galderma Investigational Site 6186
Galderma Investigational Site 6138
Galderma Investigational Site 5225
Galderma Investigational Site 6245
Galderma Investigational Site 6154
Galderma Investigational Site 6255
Galderma Investigational Site 6079
Galderma Investigational Site 6068
Galderma Investigational Site 6135
Galderma Investigational Site 8733
Galderma Investigational Site 6146
Galderma Investigational Site 8610
Galderma Investigational Site 6254
Galderma Investigational Site 5495
Galderma Investigational Site 8706
Galderma Investigational Site 6156
Galderma Investigational Site 8902
Galderma Investigational Site 8851
Galderma Investigational Site 6237
Galderma Investigational Site 6222
Galderma Investigational Site 8042
Galderma Investigational Site 6081
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Galderma Investigational Site 6040
Galderma Investigational Site 8873
Galderma Investigational Site 8836
Galderma Investigational Site 8718
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Galderma Investigational Site 5031
Galderma Investigational Site 6053
Galderma Investigational Site 8795
Galderma Investigational Site 6157
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Galderma Investigational Site 6028
Galderma Investigational Site 6204
Galderma Investigational Site 8728
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Galderma Investigational Site 8903
Galderma Investigational Site 6197
Galderma Investigational Site 8618
Galderma Investigational Site 6242
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Galderma Investigational Site 6029
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Galderma Investigational Site 8849
Galderma Investigational Site 6118
Galderma Investigational Site 8839
Galderma Investigational Site 8744
Galderma Investigational Site 6048
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Galderma Investigational Site 8125
Galderma Investigational Site 6159
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Galderma Investigational Site 8712
Galderma Investigational Site 6045
Galderma Investigational Site 6054
Galderma Investigational Site 6031
Galderma Investigational Site 8740
Galderma Investigational Site 6155
Galderma Investigational Site 5566
Galderma Investigational Site 8818
Galderma Investigational Site 6238
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title: A Phase 3, Multicenter, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Fedratinib Compared to Best Available Therapy (BAT) in Subjects With DIPSS (Dynamic International Prognostic Scoring System)-Intermediate or High-risk Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) and Previously Treated With Ruxolitinib

summary: A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (Dynamic International Prognostic Scoring System)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. The primary objective of the study is to evaluate the percentage of subjects with at least 35% spleen volume reduction in the fedratinib and the BAT arms.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

collaborators: Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation

location_country:
Germany
Ireland
Italy
Poland
Hungary
United Kingdom
Australia
Netherlands
Austria
Belgium
Korea, Republic of
China
Spain
Czechia
Russian Federation
France

location_facility:
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