title: An Open-label Phase 1/1b Study to Evaluate the Safety and Pharmacokinetics of JNJ-73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer

summary: The purpose of this study is to confirm the tolerability of recommended Phase 2 dose (RP2D) of Lazertinib (Phase 1), to determine the tolerability and identify the recommended Phase 2 combination dose of Lazertinib when combined with Amivantamab (JNJ-61186372) (Phase 1b), to characterize the safety and tolerability of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced non-small cell lung cancer (NSCLC) with documented advanced or metastatic epidermal growth factor receptor (EGFR) mutation (Phase 1b expansion cohorts A, B, C, D and E), to estimate the antitumor activity of Lazertinib and Amivantamab combinations at the RP2CD in participants with advanced NSCLC with documented advanced or metastatic EGFR mutation (Phase 1b expansion cohorts A, B, C, and D), to validate the biomarker identified in Phase 1b expansion Cohort D as a predictor of antitumor activity of Lazertinib and Amivantamab combination (Cohort E) or Amivantamab monotherapy (Cohort F) in participants with osimertinib-relapsed, chemotherapy-naïve, EGFR Exon19del or L858R mutated NSCLC, to identify the recommended Phase 2 dose (RP2ChD) of Lazertinib when combined with Amivantamab and standard of care chemotherapy and to determine the tolerability of the Lazertinib, Amivantamab, and platinum-doublet chemotherapy (LACP) combination (Phase 1b LACP combination cohort) and to characterize the safety and tolerability of Lazertinib at the RP2ChD and Amivantamab and standard of care chemotherapy in participants with advanced or metastatic EGFR-mutated NSCLC (Phase 1b LACP combination cohort), to assess 2 potential biomarker strategies to identify participants at increased, or decreased, probability of tumor response with JNJ-61186372 and lazertinib combination in participants with EGFR Exon19del or L858R mutated NSCLC progressed on or after osimertinib (Phase 1b expansion Cohort D).

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
Italy
Japan
United States
China
Korea, Republic of
Spain
Taiwan
Puerto Rico
France

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Oncologic Hospital, Puerto Rico Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Shengjing Hospital of China Medical University

location_facility: The Second Affiliated Hospital of Kunming Medical University

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: West China School of Medicine/West China Hospital, Sichuan University

location_facility: USC - Norris Comprehensive Cancer Center

location_facility: Robert-Bosch-Krankenhaus - Klinik Schillerhoehe

location_facility: The Fifth Affiliated Hospital of Guangzhou Medical University

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The First Bethune Hospital of Jilin University

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Kliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim

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


study_start_date_type: Actual

acronym: CheckMate 7A8

intervention_type: Drug

lead_sponsor: Bristol-Myers Squibb

summary: A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer

location_facility: Hematology-Oncology Associates Of Fredricksburg, Inc

location_facility: The Cancer Center At Hackensack University Medical Center

location_facility: Hospital Clinico Universitario De Valencia

location_facility: Northside Hospital,Inc.- Central Research Department

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Centre de Cancerologie du Grand Montpellier

status: Completed

title: Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Australia
Belgium
United States
Spain
Canada
Puerto Rico
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase I, Open-label, Dose Finding Study to Assess the Safety, Tolerability, PK, and Preliminary Efficacy of OBT076, a CD205-directed ADC, in Recurrent and/or Metastatic CD205+ Solid Tumors

summary:
The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC). Antibodies are normally produced in the human body by the immune system to fight infections but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is composed of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that it is still being studied and has not yet been approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The use of OBT076 in this study is investigational.

This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Oxford BioTherapeutics Ltd

location_country:
Belgium
United States
Spain
Greece
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University General Hospital of Heraklion

location_facility: University Hospital Marqués de Valdecilla

location_facility: ICANS - Institut de cancérologie Strasbourg

location_facility: University of Mississippi Medical Center

status_simplified: Ongoing


lead_sponsor: Incyte Corporation

summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

ReferenceType: derived

ReferenceCitation: Rosmarin D, Passeron T, Pandya AG, Grimes P, Harris JE, Desai SR, Lebwohl M, Ruer-Mulard M, Seneschal J, Wolkerstorfer A, Kornacki D, Sun K, Butler K, Ezzedine K; TRuE-V Study Group. Two Phase 3, Randomized, Controlled Trials of Ruxolitinib Cream for Vitiligo. N Engl J Med. 2022 Oct 20;387(16):1445-1455. doi: 10.1056/NEJMoa2118828.

oa_host_type: publisher

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Diagnostic Consultative Center II Sofia EOOD

location_facility: IDEI (Instituto de Dermatología Integral).

location_facility: Synexus Affiliate - Krakowskie Centrum Medyczne

location_facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge

location_facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie

location_facility: Center For Dermatology Cosmetic and Laser Surgery

location_facility: Synexus Polska Sp. Z O.O. Oddzial Warszawie

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: University Medical Center (Universitätsmedizin der Johannes Gutenberg-Universität Mainz)

location_facility: Hospital La Paz (Hospital Universitario La Paz )

location_facility: University Hospital Prof Dr Stoyan Kirkovich

location_facility: CENTRE HOSpITALIER UNIVERSITAIRE HENRI MONDOR

location_facility: Synexus Polska Sp. Z o.o. Oddział w Częstochowie

location_facility: Uci Beckman Laser Institute and Medical Clinic

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: UCI Health Beckman Laser Institute and Medical Center

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska

location_facility: Diagnostic Consultative Center Ii Sofia Eood

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University Hospital " Prof. Dr Stoyan Kirkovich"

location_facility: Centre Hospitalier Universitaire de Besancon

title: Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2): A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

location_country:
Germany
Italy
Poland
Netherlands
United States
Spain
Bulgaria
Canada
France


type: EudraCT Number

type: Other Identifier

title: A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, For Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)

summary: This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

design_allocation: Non-Randomized

ipd_sharing: Yes

ipd_sharing_description: De-identified individual participant data (IPD) on completed studies 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 UK Limited
Merck Sharp & Dohme LLC

location_country:
United States
Spain
United Kingdom
France

location_facility: Siteman Cancer Center-Washington University

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Institute Oncologico Baselga Hospital Quiron

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: University of California San Francisco Medical Center


acronym: COURSE

intervention_type: Other

lead_sponsor: AstraZeneca

summary: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

sponsor_collaborators: AstraZeneca Amgen

status: Active, not recruiting

title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) (COURSE)

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


title: A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer

summary: The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

ReferenceCitation: Leal TA, Ramalingam SS. Neoadjuvant therapy gains FDA approval in non-small cell lung cancer. Cell Rep Med. 2022 Jul 19;3(7):100691. doi: 10.1016/j.xcrm.2022.100691.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

ReferenceCitation: Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.

oa_host_type: repository

version: acceptedVersion

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

version: submittedVersion

repositories_concat: PubMed Central;aacr.figshare.com

unpaywall_oa_status: green

publisher_dissemination: American Association for Cancer Research

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
United States
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Spain
Taiwan
Russian Federation

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Thomas Jefferson University - Clinical Trials Office-Medical Oncology


acronym: CULMINATE

lead_sponsor: OncoVerity, Inc.

summary: The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.

sponsor_collaborators:
OncoVerity, Inc.
argenx
Janssen Research & Development, LLC

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

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

location_facility: Division of Hematology, Cardarelli Hospital

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Ankara University Medical Faculty Hematology Department - Hematology

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

title: A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

location_country:
France
Italy
Australia
Brazil
Switzerland
Spain
Turkey
Russian Federation
Israel


title: A Phase 2b, Multicentre, Randomised, Double-blind, Placebo-controlled Study of Verinurad and Allopurinol in Patients With Chronic KIdney Disease and Hyperuricaemia

acronym: SAPPHIRE

summary: The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.

ReferenceCitation: Heerspink HJL, Stack AG, Terkeltaub R, Greene TA, Inker LA, Bjursell M, Perl S, Rikte T, Erlandsson F, Perkovic V. Rationale, design, demographics and baseline characteristics of the randomized, controlled, Phase 2b SAPPHIRE study of verinurad plus allopurinol in patients with chronic kidney disease and hyperuricaemia. Nephrol Dial Transplant. 2022 Jul 26;37(8):1461-1471. doi: 10.1093/ndt/gfab237.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Illinois at Chicago - INDIGO

repositories_concat: PubMed Central;figshare.com;pure.rug.nl

unpaywall_oa_status: hybrid

publisher_dissemination: Oxford University Press

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.

location_country:
France
Italy
Poland
Slovakia
Hungary
Romania
Mexico
United States
Spain
South Africa
Czechia
Israel


acronym: MELODY

summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

ReferenceCitation: Hammitt LL, Dagan R, Yuan Y, Baca Cots M, Bosheva M, Madhi SA, Muller WJ, Zar HJ, Brooks D, Grenham A, Wahlby Hamren U, Mankad VS, Ren P, Takas T, Abram ME, Leach A, Griffin MP, Villafana T; MELODY Study Group. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022 Mar 3;386(9):837-846. doi: 10.1056/NEJMoa2110275.

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.

title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

primary_purpose: Prevention

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.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Japan
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
United States
Latvia
Ukraine
Belgium
Estonia
Italy
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Panama
South Africa
Bulgaria
Russian Federation
Israel


title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation

summary: This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

lead_sponsor: Dizal Pharmaceuticals

location_country:
Italy
Australia
Japan
United States
Korea, Republic of
Spain
Malaysia
Taiwan
France

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: Peter MacCallum Cancer Centre - East Melbourne

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

location_facility: Centro Integral Oncológico Clara Campal (CIOCC)

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: CHU de Montpellier Hôpital Arnaud de Villeneuve

location_facility: Niigata University Medical & Dental Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Northwell Health - Centers for Advanced Medicine

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele"

location_facility: ICO (Institut Catala d'Oncologia) Badalona - Hospital Germans Trias i Pujol

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center

location_facility: National Hospital Organization Shikoku Cancer Center

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

location_facility: Innovative Clinical Research Institute, LLC


acronym: BREEZE-AD-PEDS

lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.

sponsor_collaborators:
Eli Lilly and Company
Incyte Corporation

location_facility: Consultorio Privado de la Dra. Villanueva

location_facility: CRI Centro Regiomontano de Investigación

location_facility: Dr. D. Y. Patil Medical College & Hospital

location_facility: Japan National Hospital Organization Mie Hospital

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Dermatology and Ophthalmology Kume Clinic

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika

location_facility: Instituto Brasil de Pesquisa Clínica - IBPCLIN

location_facility: Thalassemia and Sickle Cell Centre Rughwani Child Care Center and Hospital

location_facility: IDERJ - Instituto de Dermatologia e Estética do Brasil

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Tula Regional Clinical Dermatovenerological Dispensary

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Instituto de Neumonología Y Dermatología

location_facility: Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology

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

title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Outpatient Study Evaluating the Pharmacokinetics, Efficacy, and Safety of Baricitinib in Pediatric Patients With Moderate to Severe Atopic Dermatitis

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
India
Hungary
Argentina
Israel
Australia
Brazil
Japan
Austria
Mexico
United Kingdom
Spain
Taiwan
Czechia
Russian Federation
France


summary: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

title: A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

location_country:
Italy
Poland
India
United Kingdom
Argentina
Hong Kong
Japan
United States
China
Korea, Republic of
Thailand
Turkey
Chile
Taiwan
Bulgaria
Russian Federation
France


acronym: POWER

lead_sponsor: Janssen-Cilag Ltd.

summary: The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

ReferenceCitation: Ten Bokkel Huinink S, Biemans V, Duijvestein M, Pierik M, Hoentjen F, West RL, van der Woude CJ, de Vries AC. Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e783-e788. doi: 10.1097/MEG.0000000000002256.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: Gastroenterology Research of America, LLC

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

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Southampton University Hospitals NHS Trust

location_facility: Universitatsklinikum Frankfurt/ Medizinische Klinik 1

location_facility: Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: Washington University School of Medicine

location_facility: Universitatsklinikum Schleswig-Holstein - Kiel

location_facility: Medizinisches Versorgungszentrum (MVZ) Dachau

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Pennine Acute Hospitals-Fairfield General Hospital

location_facility: Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's

location_facility: Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.

location_facility: University of Mississippi Medical Center

location_facility: Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II

location_facility: Gloucestershire Hospitals NHS Foundation Trust - Cheltenham

location_facility: University of Kentucky Chandler Medical Center

title: A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease

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 and Access (YODA) Project site at yoda.yale.edu

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Austria
United States
Korea, Republic of
Spain
Czechia
Russian Federation
France


acronym: MK-3475 (SCH 9000475) as neoadjuvant and adjuvant therapy in Stage III-IVA resectable LA HNSCC

lead_sponsor: Merck Sharp & Dohme LLC

summary: This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.

location_facility: Yokohama City University Hospital ( Site 0657)

location_facility: University of Utah, Huntsman Cancer Institute ( Site 1855)

location_facility: Wake Forest Compenhensive Cancer Center ( Site 2029)

location_facility: Oregon Health Science University ( Site 1871)

location_facility: Hopital Europeen Georges Pompidou ( Site 0358)

location_facility: Instituto de Oncología Angel Roffo ( Site 0003)

location_facility: Avera Cancer Institute- Research ( Site 2070)

location_facility: University of Southern California Norris Comprehensive Cancer Center ( Site 1850)

location_facility: Ukrainian Center of Tomotherapy ( Site 1708)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0550)

location_facility: University of Massachusetts Memorial Medical Center ( Site 1875)

location_facility: Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0554)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 1702)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 1859)

location_facility: Providence Portland Medical Center ( Site 1843)

location_facility: Chonnam National University Hwasun Hospital ( Site 0705)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)

location_facility: Aichi Cancer Center Hospital ( Site 0658)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0704)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)

location_facility: Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0660)

location_facility: Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)

location_facility: Hospital Britanico de Buenos Aires ( Site 0012)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1920)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0406)

location_facility: Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0153)

location_facility: Royal Brisbane and Women s Hospital ( Site 0050)

location_facility: Princess Margaret Cancer Centre ( Site 0202)

location_facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)

location_facility: Northwell Health Cancer Institute ( Site 2030)

location_facility: Tokyo Medical University Hospital ( Site 0659)

location_facility: National Cheng Kung University Hospital ( Site 1302)

location_facility: UT Southwestern Medical Center ( Site 1841)

location_facility: Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)

location_facility: National Taiwan University Hospital ( Site 1300)

location_facility: Taichung Veterans General Hospital ( Site 1301)

location_facility: Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0171)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)

location_facility: Sanford Health Roger Maris Cancer Center ( Site 2034)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 1818)

location_facility: UVA Health System - Emily Couric Cancer Center ( Site 1826)

location_facility: Rush University Medical Center ( Site 1823)

location_facility: Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)

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

location_facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)

location_facility: The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)

location_facility: Weill Cornell Medical College ( Site 2050)

location_facility: National Cancer Center Hospital ( Site 0650)

location_facility: Hoag Memoriall Hospital Presbyterian ( Site 2056)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)

location_facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 0935)

location_facility: National Cancer Center Hospital East ( Site 0661)

location_facility: George Washington University Medical Faculty Associates ( Site 2035)

location_facility: Centro Regional Integrado de Oncologia ( Site 0160)

location_facility: Oncologos del Occidente S.A. ( Site 0310)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)

location_facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)

location_facility: McGill University Health Centre ( Site 0210)

location_facility: Hospital Clinico Universitario de Santiago ( Site 1207)

location_facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)

location_facility: Washington University School of Medicine ( Site 1800)

location_facility: Sunnybrook Research Institute ( Site 0211)

location_facility: University of Colorado Cancer Center ( Site 1838)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)

location_facility: Hospital Universitario Austral ( Site 0009)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0165)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0355)

location_facility: Universitaetsklinikum Koeln ( Site 0413)

location_facility: Instituto de Oncologia de Rosario ( Site 0002)

location_facility: Hiroshima University Hospital ( Site 0655)

location_facility: Saint Alphonsus Regional Medical Center ( Site 2021)

location_facility: NorthShore University HealthSystem ( Site 1812)

location_facility: Fundacion Estudios Clinicos-Oncology ( Site 0017)

location_facility: Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)

location_facility: Universitaetsklinikum Frankfurt ( Site 0403)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0300)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054)

location_facility: St. Joseph Heritage Healthcare ( Site 1806)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0251)

location_facility: Hospital Universitario La Paz ( Site 1201)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)

location_facility: Universitaetsklinikum Hamburg Eppendorf ( Site 0407)

location_facility: University of Kansas Cancer Center ( Site 2004)

location_facility: Royal Marsden Hospital - Fulham Road London ( Site 1609)

location_facility: Clinical oncology dispensary of Dnipro ( Site 1706)

location_facility: Chaim Sheba Medical Center. ( Site 0553)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1206)

location_facility: Universitätsklinikum Schleswig-Holstein ( Site 0411)

location_facility: Kyiv City Clinical Oncology Centre ( Site 1701)

location_facility: Centro de Investigacion Clinica del Country ( Site 0304)

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1857)

location_facility: Loyola University Medical Center [Maywood, IL] ( Site 1817)

location_facility: University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)

location_facility: Hospital Aleman Buenos Aires Argentina ( Site 0004)

location_facility: Inova Schar Cancer Institute ( Site 2026)

location_facility: Orszagos Onkologiai Intezet ( Site 0454)

location_facility: Tokyo Medical and Dental University Hospital ( Site 0654)

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 1604)

location_facility: Orlando Health Cancer Institute ( Site 2061)

location_facility: St. Luke's University Health Network ( Site 1801)

location_facility: Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)

location_facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)

location_facility: Hospital Provincial del Centenario ( Site 0008)

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)

location_facility: Medizinische Universität Wien ( Site 1903)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)

location_facility: University of Vermont Medical Center ( Site 2009)

location_facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)

location_facility: The University of New Mexico Comprehensive Cancer Center ( Site 1882)

location_facility: Seoul National University Bundang Hospital ( Site 0703)

location_facility: Severance Hospital, Yonsei University Health System ( Site 0701)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 2071)

location_facility: Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)

location_facility: University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)

location_facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)

location_facility: MedStar Washington Hospital Center ( Site 2062)

title: A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)

type: Registry Identifier

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Colombia
Portugal
Hungary
Switzerland
United States
Ukraine
Belgium
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

summary: The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

lead_sponsor: Rigel Pharmaceuticals

location_country:
Germany
Australia
Czechia
Canada
Serbia
France
Belarus
Hungary
Denmark
United States
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Bulgaria
Georgia
Russian Federation

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases EAD, Sofia, Clinic of Clinical Haematology

location_facility: Universitätsklinik Innsbruck - Innere Medizin V

location_facility: State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

location_facility: Banner MD Anderson Cancer Center at North Colorado Medical Center

location_facility: Aarhus University Hospital - Dept of Hematology

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region "City Clinical Hospital №2"

location_facility: Texas Oncology - Baylor Research Institute

location_facility: SCDU Ematologia AOU "Maggiore della Carità"

location_facility: American Oncology Network Vista Oncology Division

location_facility: Hospital Universitario y Politecnico La Fe - Servicio de Hematología

location_facility: Arizona Oncology Associates, PC--HOPE Division

location_facility: University Multiprofile Hospital for Active Treatment - Dr Georgi Stranski EAD, Pleven, Clinic of Clinical Haematology

location_facility: Hamilton Health Sciences- McMaster University Medical Centre

location_facility: CHU Estaing - Chirurgie digestive et Médecine interne

location_facility: Fakultni nemocnice Ostrava Klinika hematoonkologie

location_facility: Clinical Centre of Vojvodina, Clinic for Hematology

location_facility: Pécsi Tudományegyetem, Klinikai Központ, I.számú Belgyógyászati Klinikai, Hematológiai Tanszék

location_facility: East Kent Haemophilia Centre, Kent and Canterbury Hospital

location_facility: "Prof. Dr. Ion Chiricuta" Institute of Oncology Cluj-Napoca

location_facility: Rutgers - Robert Wood Johnson Medical School

location_facility: The Royal London Hospital, Bart's Health NHS Trust

location_facility: Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

location_facility: Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

location_facility: Ospedale Maggiore, SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina

location_facility: Kyiv City Clinical Hospital №9, hematology department №1

location_facility: Cherkasy Regional Oncology Dispensary, Hematology Center

location_facility: LTD Multiprofile Clinic Consilium Medulla

location_facility: University Multiprofile Hospital for Active Treatment 'Sv. Ivan Rilski' EAD, Clinic of Clinical Hematology, Department of Clinical Hematology

location_facility: Regional State Autonomous Healthcare Institution "Tomsk Regional Clinical Hospital"

location_facility: Institut d'hématologie de Basse Normandie, CHU Caen

location_facility: Princess Alexandra Hospital - Cancer Trials Unit

location_facility: University Multiprofile Hospital for Active Treatment 'Alexandrovska' EAD, Clinic of Clinical Haematology

location_facility: University Hospital Medical Center "Bezanijska Kosa", Department of Hematology

location_facility: The Oncology Institute of Hope and Innovation

location_facility: ASST degli Spedali Civili di Brescia, Ematologia UOC

location_facility: City Clinical Hospital № 4, Hematology Center

location_facility: University of Leipzig Medical Center, Medical Department I - Haematology and Cell Therapy, Medical Oncology, Hemophilia

location_facility: CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses

location_facility: State Budgetary Healthcare Institution of Moscow city "City Clinical Hospital No 40 Department of Healthcare of Moscow city"

location_facility: Semmelweis Egyetem, Általános Orvostudományi Kar, I.sz. Belgyógyászati Klinika, Haematológiai Osztály,

location_facility: Clinical Center Nis, Clinic for Hematology

location_facility: ULSS8 Berica Ospedale San Bortolo - Unità Operativa Complessa di Ematologia

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: University Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD, Varna, Clinic of Clinical Haematology

location_facility: Universitair Ziekenhuis Antwerpen - Hematologie

location_facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia

location_facility: Marshfield Clinic Cancer Center - Stevens Point


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Patients With Manifest Huntington's Disease

summary: This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

ReferenceCitation: Rodrigues FB, Ferreira JJ, Wild EJ. Huntington's Disease Clinical Trials Corner: June 2019. J Huntingtons Dis. 2019;8(3):363-371. doi: 10.3233/JHD-199003.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: IOS Press

ReferenceCitation: Rodrigues FB, Quinn L, Wild EJ. Huntington's Disease Clinical Trials Corner: January 2019. J Huntingtons Dis. 2019;8(1):115-125. doi: 10.3233/JHD-190001.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: UCL Discovery

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
New Zealand
United Kingdom
Argentina
Denmark
Australia
Japan
Netherlands
Austria
Switzerland
United States
Spain
Chile
Canada
Russian Federation
France

location_facility: St. Josef-Hospital, Neurologische Klinik der Ruhr-Uni; Huntington-Center NRW, Abt. Neurodegeneration

location_facility: Fundacion Jimenez Diaz; Servicio de Neurología

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: National Hospital For Neurology and Neurosurgery

location_facility: WESTMEAD HOSPITAL; Deparment of Neurology

location_facility: The University of Texas Health Science Center at Houston; McGovern Medical School

location_facility: University of California Davis Medical System

location_facility: National Hospital Organization Niigata National Hospital

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: Centro de Trastornos del Movimiento (CETRAM); CETRAM

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Centre Hospitalier de l?Université de Montréal (CHUM)

location_facility: University of Utah Clinical Neurosciences Center

location_facility: IRCCS Istituto delle Scienze Neurologiche; UOC Clinica Neurologica

location_facility: John Hopkins University School of Medicine

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: Uniklinik RWTH Aachen; Klinik für Neurologie

location_facility: CenExel Rocky Mountain Clinical Research, LLC

location_facility: IRCCS Casa Sollievo Della Sofferenza; Unità Ricerca e Cura Huntington e Malattie Rare

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hôpital Pitié Salpêtrère; Département de Génétique et Cytogénétique

location_facility: Cambridge Centre for Brain Repair; Department of Clinical Nuerosciences, Addenbrookes Hospital

location_facility: Research Center of Neurology; Neurology Department #5

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: University of British Columbia Hospital; Division of Neurology

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

location_facility: Hopital Roger Salengro Service de Neurologie

location_facility: Szpital Sw. Wojciecha; Oddzial Neurologiczny

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Aberdeen Royal Infirmary; Medical Genectics

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: University Hospital of Wales; Division of Psychological Medicine and Clinical Neurosciences

location_facility: Universitätsklinikum Erlangen, Abteilung Molekulare Neurologie

location_facility: Washington University School of Medicine

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

location_facility: A.O.U. Careggi; Diaprtimento Scienze Neurologiche e Psichiatriche

location_facility: Hospital Universitario de Badajoz; Servicio de Neurología

location_facility: Auckland DHB - Neurlogy Department; Neurology Department

location_facility: Okayama University Graduate School of Medicine, Densitry and Pharmaceutical Sciences.

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta; U.O.C. Genetica Medica-Neurogenetica

location_facility: Hopital Henri Mondor; Service de Neurologie

location_facility: National Center of Neurology and Psychiatry

location_facility: Wellington Hospital; Department of Neurology

location_facility: Aarhus Universitetshospital; Neurologisk Afdeling F, Neurogenetisk Afsnit

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Queen Elizabeth University Hospital Glasgow

location_facility: ?linical hospital at Kazan station, Republican Center for Movement Disorders and Botulinum Therapy

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Zentrum für Seltene Erkrankungen

location_facility: Charité - Universitätsmed. Berlin, Klinik für Psychiatrie und Psychotherapie; Abt. Neuropsychiatrie

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: George-Huntington- Institut GmbH; Technologiepark Münster

location_facility: German Center for Neurodegenerative Diseases (DZNE)

location_facility: CHU Angers, Batiement Larrey 2, Neurologie

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Central Manchester University Hospitals NHS Foundation Trust; Manchester Centre for Genomic Medicine

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Georgetown University; Research Division, Psychiatry


acronym: METEORIC-HF

lead_sponsor: Cytokinetics

summary: The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo

ReferenceCitation: Lewis GD, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Bohm M, Teerlink JR, Docherty KF, Lopes RD, Divanji PH, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Felker GM. Effect of Omecamtiv Mecarbil on Exercise Capacity in Chronic Heart Failure With Reduced Ejection Fraction: The METEORIC-HF Randomized Clinical Trial. JAMA. 2022 Jul 19;328(3):259-269. doi: 10.1001/jama.2022.11016.

repositories_concat: PubMed Central;pure.rug.nl

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

publisher_dissemination: American Medical Association

ReferenceCitation: Lewis GD, Docherty KF, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Ponikowski P, Bohm M, Teerlink JR, Heitner SB, Kupfer S, Malik FI, Meng L, Felker GM. Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF. Circ Heart Fail. 2022 May;15(5):e008970. doi: 10.1161/CIRCHEARTFAILURE.121.008970. Epub 2022 Mar 3.

evidence: open (via page says license)

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

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

repository_normalized: HAL

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

repository_institution: The University of Glasgow - Enlighten: Publications

location_facility: Enhet Klinisk forskning, hjartmedicin, Skanes Universitet Sjukhus

location_facility: Baylor Scott and White Heart and Vascular Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologiczny

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Universitair Medisch Centrum Utrecht - Wilhelmina Kinderziekenhuis

location_facility: Mcgill University Health Centre (MUHC)-The Montreal General Hospital (MGH)

location_facility: Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)

location_facility: Centrum Chorob Serca, Uniwersytecki Szpital Kllniczny im. Jana Mikulicza Radeckiego we Wrociawiu

location_facility: Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

location_facility: Uniwersyteckie Centrum Kliniczne Kliniczne Centrum Kardiologii

location_facility: Hartford Hospital-University of Connecticut School of Medicine

location_facility: University of Texas - Southwestern Medical Center

location_facility: Semmelweis University Heart and Vascular Center

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: Massachusetts General Hospital (MGH) - Cardiac Unit Associates

location_facility: Universite De Nantes - L'Institut Du Thorax

location_facility: Onze Lieve Vrouwe Gasthuis (OLVG) Locatie West

location_facility: Erasmus MC - Universitair Medisch Centrum Rotterdam

location_facility: Broward Research Center - Pembroke Pines

location_facility: Instytut Kardiologii Heart Failure Clinic

location_facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere

location_facility: Oddzial Kliniczny Choroby Wiencowej i Niewydolnosci Serca z Pododdzialem Intensywnego Nadzoru Kardiologicznego

location_facility: Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)

location_facility: Universite de Montreal Institut de Cardiologie de Montreal ICM Montreal Heart Institute MHI

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Glacier View Research Institute, Cardiology

location_facility: Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana

location_facility: Cardiovascular Associates Of The Delaware Valley (Cadv), P.A. - Elmer Physicians Care Center - Elmer

location_facility: London Health Sciences Centre - University Hospital

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil

location_facility: Wake Forest University School of Medicine

location_facility: Divisione di Cardiologia con Utic ed Emodinamica

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance

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

location_country:
Germany
Italy
Poland
Hungary
Sweden
Netherlands
United States
Canada
France


summary:
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in combination with chemotherapy (Cisplatin combined with 5-Fluorouracil [FP regimen] or oxaliplatin combined with capecitabine [CAPOX regimen]) versus placebo in combination with chemotherapy (FP or CAPOX regimens) in the treatment of human epidermal growth factor receptor 2 (HER2) negative advanced gastric or GEJ adenocarcinoma in adult participants.

The primary hypotheses of this study are that pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy in terms of overall survival (OS).

ReferenceCitation: Tabernero J, Bang YJ, Van Cutsem E, Fuchs CS, Janjigian YY, Bhagia P, Li K, Adelberg D, Qin SK. KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Aug;17(22):2847-2855. doi: 10.2217/fon-2021-0176. Epub 2021 May 12. Erratum In: Future Oncol. 2023 Jun;19(17):1229.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: Future Science Ltd

location_facility: Blokhin National Medical Oncology ( Site 1604)

location_facility: Peking Union Medical College Hospital ( Site 2425)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0405)

location_facility: Harbin Medical University Cancer Hospital ( Site 2401)

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 1504)

location_facility: Changzhou Cancer Hospital-Changzhou Fourth Peoples Hospital ( Site 2441)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 1703)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 1708)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2001)

location_facility: Peking University Shenzhen Hospital ( Site 2442)

location_facility: Princess Margaret Hospital. ( Site 2502)

location_facility: Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi ( Site 2006)

location_facility: Severance Hospital Yonsei University Health System ( Site 2800)

location_facility: Masarykuv onkologicky ustav ( Site 3103)

location_facility: Princess Margaret Cancer Centre ( Site 0203)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2204)

location_facility: National Cancer Center Hospital ( Site 2606)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0901)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 2902)

location_facility: City Clinical Oncology Center ( Site 1603)

location_facility: Instituto Nacional de Cancerologia. ( Site 0804)

location_facility: National Taiwan University Hospital ( Site 2900)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 2205)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 1616)

location_facility: Zhejiang Provincial People's Hospital ( Site 2446)

location_facility: Universitaetsklinikum Leipzig ( Site 1114)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 1413)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0902)

location_facility: Aalborg University Hospital ( Site 3204)

location_facility: University of Debrecen Medical Center Clinic of Oncology ( Site 3300)

location_facility: Ibaraki Prefectural Central Hospital ( Site 2610)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 1704)

location_facility: National Cancer Center Hospital East ( Site 2617)

location_facility: Universitaetsspital Zuerich ( Site 1902)

location_facility: The First Hospital of Jilin University ( Site 2416)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 1700)

location_facility: Hospital de Caridade de Ijui ( Site 0402)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0501)

location_facility: Christus Muguerza Clinica Vidriera ( Site 0802)

location_facility: Hospital Universitario General de Asturias ( Site 1802)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1801)

location_facility: Trakya Universitesi Tip Fakultesi ( Site 2015)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0401)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 2436)

location_facility: Yancheng First People s Hospital ( Site 2426)

location_facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 3000)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2200)

location_facility: Clinica Ricardo Palma Instituto de Oncologia y Radioterapia ( Site 0908)

location_facility: Soroka University Medical Center ( Site 1305)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2208)

location_facility: McGill University Health Centre ( Site 0208)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 2407)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2609)

location_facility: Wenatchee Valley Clinic [Wenatchee, WA] ( Site 0116)

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

location_facility: Malatya Inonu Universitesi Tip Fakultesi Hastanesi ( Site 2009)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 2012)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 2430)

location_facility: Instituto Medico Alexander Fleming ( Site 0307)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1004)

location_facility: Kansai Medical University Hospital ( Site 2608)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1905)

location_facility: The Affiliated Hospital of Qingdao University ( Site 2405)

location_facility: Niigata Cancer Center Hospital ( Site 2613)

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Gyula Korhaz-Rendelointezet ( Site 3302)

location_facility: Minnesota Oncology Hematology, PA ( Site 8000)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0604)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2011)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 1907)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 2440)

location_facility: 1st Affil hosp of Med College of Xi'an Jiaotong University ( Site 2428)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2611)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 1806)

location_facility: Instituto de Investigaciones Metabolicas ( Site 0312)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 1503)

location_facility: City Clinical Hosp.4 of DCC ( Site 2201)

location_facility: Kobe City Medical Center General Hospital ( Site 2603)

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary-Chemotherapy ( Site 1608)

location_facility: Instituto do Cancer do Ceara ( Site 0407)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0808)

location_facility: Zhongshan Hospital Xiamen University ( Site 2447)

location_facility: Seoul National University Hospital ( Site 2803)

location_facility: Cancercare Rondebosch Oncology ( Site 1709)

location_facility: MI Odessa Regional Oncological Centre ( Site 2212)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 1007)

location_facility: Fakultni Thomayerova nemocnice ( Site 3101)

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 3104)

location_facility: Fujian Provincial Cancer Hospital ( Site 2414)

location_facility: Sunnybrook Research Institute ( Site 0202)

location_facility: Edith Wolfson Medical Center ( Site 1307)

location_facility: Odense Universitets Hospital ( Site 3201)

location_facility: Xiangya Hospital Central-South University ( Site 2419)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 2421)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1804)

location_facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2000)

location_facility: Tallaght University Hospital ( Site 1202)

location_facility: Regionalny Szpital Specjalistyczny im Wl. Bieganskiego w Grudziadzu ( Site 1505)

location_facility: Clinic of National Cancer Institute ( Site 2203)

location_facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 0113)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 2612)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0605)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 1609)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0403)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0400)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 3001)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0703)

location_facility: Southern Medical Day Care Centre ( Site 2303)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0404)

location_facility: Kumamoto University Hospital ( Site 2602)

location_facility: National Cheng Kung University Hospital ( Site 2901)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 2210)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0608)

location_facility: Greater Baltimore Medical Center ( Site 0102)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1301)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1805)

location_facility: Cancer Treatment Centers of America - Philadelphia ( Site 0112)

location_facility: Hospital General Universitario de Elche ( Site 1803)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1614)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0124)

location_facility: University College London Hospital ( Site 1211)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1506)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2420)

location_facility: Aichi Cancer Center Hospital ( Site 2619)

location_facility: The Oncology Centre Overport and Umhlanga ( Site 1705)

location_facility: Medical Centre LLC Oncolife ( Site 2202)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 2605)

location_facility: Hacettepe University Medical Faculty ( Site 2017)

location_facility: Kitasato University Hospital ( Site 2618)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2213)

location_facility: Osaka International Cancer Institute ( Site 2607)

location_facility: Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 8001)

location_facility: Orszagos Onkologiai Intezet ( Site 3303)

location_facility: Fujian Medical University Union Hospital ( Site 2410)

location_facility: Istituto Nazionale dei Tumori Fondazione IRCSS ( Site 1402)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0500)

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 0806)

location_facility: Centro Oncologico Riojano Integral ( Site 0313)

location_facility: Charite Universitaetsmedizin Berlin ( Site 1101)

location_facility: South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 1205)

location_facility: Universitas Annex National Hospital ( Site 1701)

location_facility: Istituto Europeo di Oncologia ( Site 1411)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0502)

location_facility: Fundacion Favaloro - Hospital Universitario ( Site 0302)

location_facility: Medical Care and Research S.A. de C.V. ( Site 0809)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1204)

location_facility: UC Irvine Health/Division of Hematology Oncology, Dept of Medicine ( Site 0128)

title: A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Costa Rica
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
China
Peru
Italy
Guatemala
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

summary: The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ cancer.

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.

location_country:
Germany
Italy
Poland
Norway
Argentina
Singapore
Australia
United Kingdom
Austria
Belgium
United States
Spain
Chile
Czechia
Canada
Puerto Rico
France

location_facility:
Local Institution - 0075
Local Institution - 0021
Local Institution - 0011
Local Institution - 0009
Local Institution - 0071
Local Institution - 0077
Local Institution - 0035
Local Institution - 0072
Local Institution - 0095
Local Institution - 0058
Local Institution - 0005
Local Institution - 0014
Local Institution - 0034
Local Institution - 0063
Local Institution - 0016
Local Institution - 0008
Local Institution - 0078
Local Institution - 0099
Local Institution - 0087
Local Institution - 0046
Local Institution - 0036
Local Institution - 0031
Hoag Memorial Hospital Presbyterian
Virginia Cancer Institute
Local Institution - 0054
Local Institution - 0090
Local Institution - 0070
Local Institution - 0024
Local Institution - 0069
Local Institution - 0033
IRCCS Istituto Nazionale Tumori Milano
Local Institution - 0079
Local Institution - 0060
Local Institution - 0082
Local Institution - 0083
Local Institution - 0067
Local Institution - 0059
Local Institution - 0081
Local Institution - 0040
Local Institution - 0038
Local Institution - 0028
Local Institution - 0064
Local Institution - 0091
Local Institution - 0061
Local Institution - 0052
Local Institution - 0043
Local Institution - 0047
Local Institution - 0049
Local Institution - 0050
Local Institution - 0010
Local Institution - 0089
Local Institution - 0017
Local Institution - 0029
Local Institution - 0030
Local Institution - 0057
Local Institution - 0003
Local Institution - 0018
Local Institution - 0041
Local Institution - 0092
Local Institution - 0080
Local Institution - 0015
Local Institution - 0027
Local Institution - 0007
Local Institution - 0055
Local Institution - 0002
Local Institution - 0032
Local Institution - 0073
Local Institution - 0012
Local Institution - 0020
Local Institution - 0062
Local Institution - 0001
Local Institution - 0086
Local Institution - 0013
Local Institution - 0056
Local Institution - 0045
Scripps Clinic
Local Institution - 0093
Local Institution - 0098
Local Institution - 0088


title: XENERA™1: A Multi-centre, Double-blind, Placebo-controlled, Randomised Phase II Trial to Compare Efficacy of Xentuzumab in Combination With Everolimus and Exemestane Versus Everolimus and Exemestane in Women With HR+ / HER2- Metastatic Breast Cancer and Non-visceral Disease

summary: The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

ReferenceCitation: Schmid P, Sablin MP, Bergh J, Im SA, Lu YS, Martinez N, Neven P, Lee KS, Morales S, Perez-Fidalgo JA, Adamson D, Goncalves A, Prat A, Jerusalem G, Schlieker L, Espadero RM, Bogenrieder T, Huang DC, Crown J, Cortes J. A phase Ib/II study of xentuzumab, an IGF-neutralising antibody, combined with exemestane and everolimus in hormone receptor-positive, HER2-negative locally advanced/metastatic breast cancer. Breast Cancer Res. 2021 Jan 15;23(1):8. doi: 10.1186/s13058-020-01382-8.

repository_institution: Seoul National University - Seoul National University Open Repository

repositories:
LIRIAS (KU Leuven)
PubMed Central
s-space.snu.ac.kr

repositories_concat: LIRIAS (KU Leuven);PubMed Central;s-space.snu.ac.kr

publisher_dissemination: Springer-Nature

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

studies in products where Boehringer Ingelheim is not the license holder;
studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Portugal
United Kingdom
Australia
Belgium
United States
Spain
Greece
Canada
France

location_facility: Istituto Nazionale IRCCS Tumori Fondazione Pascale

location_facility: University General Hospital of Heraklion

location_facility: Euromedica Kyanous Stavros General Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Regional Universitario de Málaga

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Kortrijk - HOSP AZ Groeninge Kennedylaan

location_facility: Hematology Oncology Associates of Rockland

location_facility: The Center for Cancer and Blood Disorders

location_facility: University Hospital of Larisa, Oncology Clinic


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or equal to 28 days and less than or equal to 3 years of age with respiratory syncytial virus (RSV) disease (hospitalized participants [Cohort 1] or outpatients [Cohort 2]).

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: National Hospital Organization Beppu Medical Center

location_facility: Universidade Federal De Minas Gerais - Hospital das Clínicas

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Children Outpatient Clinic 45 Of Nevskiy Region

location_facility: Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu)

location_facility: Debreceni Egyetem Klinikai Központ,Infektológiai Klinika

location_facility: Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: SUNY Upstate Medical University - Upstate Golisano Children's Hospital (GCH)

location_facility: Nowon Eulji Medical Center, Eulji University

location_facility: Dipartimento di Pediatria dell'Ospedale Luigi Sacco

location_facility: Hospital Central Militar Cirujano Mayor Dr Cosme Argerich

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

location_facility: Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy im. Rudnikow w Rabce-Zdroj, Oddzial Pulmonologii

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

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: Santa Casa de Misericórdia de Votuporanga

location_facility: Nucleo de Pesquisa do Hospital Pequeno Princípe

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Yaroslavl State Medical University Based On Children Polyclinics #5

location_facility: CMPC - Consultoria Médica e Pesquisa Clínica

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o.o.

location_facility: Saglik Bilimleri University Sariyer Hamidiye Etfal Training and Research Hospital

location_facility: Semmelweis Egyetem, II. sz. Gyermekgyógyászati Klinika

location_facility: City Children Clinical Outpatient Clinic #5

location_facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

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

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: ASST Fatebenefratelli Sacco / Ospedale dei Bambini V. Buzzi

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

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

location_facility: Shirao Clinic of Pediatrics and Pediatric Allergy

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Queen Sirikit National Institute of Child Health

location_facility: Szpital im. Swietej Jadwigi Slaskiej, Oddział Pediatryczny z Pododdziałem Niemowlęcym

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes

location_facility: Zespol Opieki Zdrowotnej w Debicy, Oddzial Dzieciecy

location_facility: Osrodek Badan Klinicznych In-Vivo Sp. z o.o.

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddzial Pediatrii i Neurologii Dzieciecej

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

location_facility: Infectious Clinical Hospital #1 Of The Moscow City Health Department

location_facility: Tropical Medicine Hospital, Mahidol University

location_facility: Department of Pediatrics University of Pavia, Policlinico San Matteo

status: Terminated

title: A Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Relationships of Different Doses of JNJ-53718678 in Children >=28 Days and <=3 Years of Age With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus Infection

location_country:
Germany
Poland
Argentina
Japan
Brazil
Thailand
Turkey
France
Hungary
United States
Belgium
Malaysia
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden

status_simplified: Unknown


title: An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

acronym: ALITHIOS

summary:
The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Poland
Argentina
Australia
Japan
Thailand
Turkey
Croatia
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
India
Belgium
Peru
Estonia
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

intervention_type: Biological


title: An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

summary: The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Germany
Italy
Argentina
Hong Kong
Japan
Brazil
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Canada
Ukraine
France

location_facility: Azienda Ospedaliera San Giuseppe Moscati - U.O Oncologia Medica

location_facility: Oncology Specialties, PC; Clearview Cancer Institute

location_facility: Vivantes Klinikum Am Urban - Haematologie und Onkologie

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital - Oncology Department

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC - Menorah Medical Center - Oncology Account

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

location_facility: Baptist Health Lexington Oncology Associates

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: University General Hospital of Heraklion "PAGNI"

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia - Faculdade de Medicina do ABC

location_facility: Cancer Institute Hospital of JFCR - Dept of Respiratory Medicine

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

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

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

location_facility: Asklepios Fachkliniken Muenchen-Gauting - Abteilung Internistische Onkologie

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - Medicina Oncologica I

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: National Cancer Center Hospital - Dept of Respiratory Medicine

location_facility: CI Transcarpathian Cl Onc Center Dep of Surgery#1 SHEI Ivano-Frankivsk NMU - Chair of Oncology

location_facility: IRCCS Centro di Riferimento Oncologico - Oncologia Medica A

location_facility: The Chinese University of Hong Kong - Emergency Medicine

location_facility: Stronach Regional Cancer Centre - at Southlake

location_facility: Maastricht University Medical Center - Dept of Medical Oncology

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Universitaetsklinikum Regensburg - Klinik und Poliklinik fuer Innere Medizin II

location_facility: Hôpital Nord - AP-HM Marseille# - Service d'Oncologie Multidisciplinaire

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: Hospital Universitario Virgen Macarena - Servicio de Oncologia

location_facility: Hospital Regional Universitario de Malaga

location_facility: Universitair Medisch Centrum Groningen (UMCG) - Parent

location_facility: CCCH City Oncological Center SHEI Uzhgorod NU - Ch of R&O of Faculty of PGE&PUT

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

location_facility: Trakya University Medical Faculty - Medical Oncology

location_facility: Rocky Mountain Cancer Centers - Colorado Springs, N. Nevada

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico - Unità Operativa di Oncologia

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha

location_facility: Decatur Memorial Hospital - Clinical Research

location_facility: Cancer Specialists, LLC - Department of Clinical Research

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

location_facility: Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: The University of Chicago Medical Center

location_facility: Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica

location_facility: CRIO - Centro Regional Integrado de Oncologia

location_facility: NHO Hokkaido Cancer Center - Dept of Respiratory Medicine

location_facility: CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique

location_facility: Kocaeli University Research and Application Hospital

location_facility: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario - Centro Oncologico

location_facility: Università degli studi della Campania Luigi Vanvitelli - Dipartimento di Oncologia

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: General Hospital Papageorgiou-2nd Department of Dermatalogy

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Oncologia Medica

location_facility: Adana Numune Training and Research Hospital - Cardiology Department

location_facility: Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic

location_facility: Medizinische Hochschule Hannover - Pneumologie

location_facility: Communal Non-profit Enterprise Regional Center of Oncology - Parent

location_facility: Medical and Preventive Treatment Institution Volyn Regional Oncological Dispensary - Dept of Oncochemotherapy

location_facility: Saitama Medical University International Medical Center - Dept of Respiratory Medicine

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: CHU Rennes - Hopital Pontchaillou - service de pneumologie

location_facility: Universitaetsklinikum Schleswig- Holstein Campus Luebeck


acronym: NOVA

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).

location_facility: Dr Wei Jing Loo Medicine Professional Corporation

location_facility: University of Pittsburgh Department of Dermatology

location_facility: Groupe Hospitalier La Rochelle - Re - Aunis

location_facility: Charite - Universitatsmedizin Berlin (CCM)

location_facility: York Dermatology Clinic and Research Centre

title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study to Evaluate Guselkumab for the Treatment of Subjects With Moderate to Severe Hidradenitis Suppurativa

location_country:
Germany
Denmark
Netherlands
United States
Canada
France