type: Registry Identifier

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

summary: The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

lead_sponsor: Gilead Sciences

location_country:
Germany
Poland
Australia
Czechia
Canada
France
Hungary
Hong Kong
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Universitatsklinikum Dusseldorf, Klink fur Hamatologie, Onkologie und Klinische Immunologie

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Amphia Hospital, department Oncologie, Route 43

location_facility: Monash University, Eastern Health-Box Hill Hospital

location_facility: Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika

location_facility: Ziekenhuis Netwerk Antwerp (ZNA) - Stuivenberg

location_facility: Klinikum rechts der Isar Technischen Universitat Munchen

location_facility: Klinikum Oldenburg, Rahel-Straus-Straße 10

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

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Providence Cancer Institute Franz Clinic

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Medizinische Hochschule Hannover, Hamatologie, Hamostaseologie, Onkologie und Stammzelltrandsplantation

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: St George Hospital, Clinical Research Unit Haemotology, Division of Cancer Services

location_facility: Universitatsklinikum Ulm, Zentrum fur Innere Medizin, Klinik fur Innere Medizin III

location_facility: Universitatsklinikum Frankfurt Goethe Universitat Med. Klink II

location_facility: University Hospitals Cleveland Medical Center

location_facility: Marien Hospital Dusseldorf GmbH, Klinik Fur Onkologie, Hamatologie Und Palliativmedizin

location_facility: University Hospital Leuven (UZ Leuven) - Campus Gasthuisberg

location_facility: Städtisches Klinikum Braunschweig GmbH Medizinische Klinik III/Hämatologie und Onkologie

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Centre Hospitalier Universitaire Nantes - Hotel Dieu

location_facility: UC Irvine Health- Chao Family Comprehensive Cancer Center

location_facility: Amsterdam Universitair Medische Centra-Locatie Vrije Universiteit Medisch Centrum

location_facility: New York-Presbyterian/Weill Cornell Medical Center

location_facility: Queen Elizabeth II (QEII) Health Sciences Centre

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Houston Methodist Hospital Cancer Center

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika FN Brno a LF MU

location_facility: Hospital Regional Universitario de Malaga

location_facility: Oxford University Hospitals NHS Foundation Trust, Churchill Hospital

location_facility: Novant Health Cancer Institute Hematology- Charlotte

location_facility: Fakultni nemocine Olomouc, Hemato-onkologicka klinika

location_facility: Icahn School of Medicine at Mount Sinai and The Mount Sinai Hospital

location_facility: Szpital Wojewodozki w Opolu Sp. z 0.0. Oddzial Klinixzny Hematologii, Onkologii Hematologicznej i Chorob Wemnetrznych

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Azienda Sanitaria Territoriale Pesaro e Urbino - "Stabilimento Ospedaliero San Salvatore - Muraglia" - U.O. Ematologia e Centro Trapianti

location_facility: Novant Health Cancer Institute Hematology - Forsyth

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M.Kopernika w Lodzi, Oddzial Hematologii Ogolnej

location_facility: Johannes Wesling Klinikum Minden Universitätsklinik fur Hämatologie, Onkologie, Hämostaseologie und Pastativrndezin, Universitatsklinik der Ruhr-Unive

location_facility: Medisch Spectrum Twente - Enschede Koningsplein

location_facility: Fakultni nemocnice Ostrava, Klinika hematoonkologie

location_facility: Wiener Gesundheitsverbund, Klinik Hietzing

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Universitatsklinikum Regensburg, Klink fur Innere Medizin III

location_facility: SSM Health Saint Louis University Hospital

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

location_facility: Institut de Cancérologie Strasbourg Europe (ICANS)

location_facility: Azienda Ospedaliero Universitaria delle Marche - SOD Clinica di Ematologia

location_facility: Princess Margaret Cancer Centre - University Health Network

location_facility: Malteser Krankenhaus St. Franziskus Hospital,Med.Klinik I

location_facility: UNC Hospitals, The University of North Carolina at Chapel Hill

location_facility: Azienda Ospedaliera di Perugia - Santa Maria della Misericordia

location_facility: Debreceni Egyetem Klinikai Központ Belgyogyaszati Klinika B epulet Hematologia

location_facility: The University of Iowa Hospitals and Clinics

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Kozpont

location_facility: Newcastle upon Tyne Hospitals Foundation Trust

location_facility: Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli, Oddzial Hematologiczny

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust

location_facility: South Warwickshire University NHS Foundation Trust

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clinico

location_facility: Charite - Universitatsmedizin Berlin, Campus Virchow Klinikum, Medizinische Klinik mit Schwerpunkt Hamatologie, Onkologie und Tumorimmunologie

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: Petz Aladár Egyetemi Oktató Kórház II. Belgyógyaszat - Haematológia

location_facility: Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika, Hematologicka ambulance

location_facility: Centre Integre Universitaire de Sante et de Services Sociaux(CIUSSS) de l'Est-de-L'Ile-de- Montreal - Hopital Maisonneuve-Rosemont

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT)-Oncopole

location_facility: Oslo University Hospital, Department of Hematology

location_facility: MidAmerica Division, Inc., c/o Research Medical Center

location_facility: Fakulti nemocnice Kralovske Vinohrady, Internf hematologicka klinika FNKV a 3. LF UK

location_facility: Froedtert Hospital and the Medical College of Wisconsin


type: EudraCT Number

title: A Randomised, Double-blind, Placebo-controlled, Multi-center Sequential Phase 2b and Phase 3 Study to Evaluate the Efficacy and Safety of AZD4831 Administered for Up to 48 Weeks in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%

acronym: ENDEAVOR

summary: This is a randomised, double-blind, placebo-controlled, multi-center sequential phase 2b and Phase 3 study to evaluate the efficacy and safety of AZD4831 administered for up to 48 Weeks in participants with heart failure with left ventricular ejection fraction > 40%. The study will consist of 2 separate parts, Part A and Part B, approximately 660 participants will be randomised in Part A, 820 in Part B.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Poland
Slovakia
Hungary
Denmark
Australia
Brazil
Japan
Netherlands
Belgium
Sweden
United States
Turkey
Taiwan
Czechia
Bulgaria
Canada
Russian Federation
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

title: A Phase 2, Open-Label, Multi-Center, Randomized Study of TAR-200 in Combination With Cetrelimab and Cetrelimab Alone in Participants With Muscle-Invasive Urothelial Carcinoma of the Bladder Who Are Scheduled for Radical Cystectomy and Are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy

summary: The purpose of this study is to evaluate the anti-tumor effects of TAR-200 in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

status: Recruiting

enrollment_type: Anticipated

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
France
Italy
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Israel

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Centre Interuniversitaire Ambroise Pare - Ambroise Paré

location_facility: Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center

location_facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

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

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

location_facility: University of Washington School of Medicine

location_facility: New York University Langone Medical Center

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Pusan National University Yangsan Hospital

location_facility: Ospedale San Giuseppe Moscati di Avellino

location_facility: UAMS Winthrop P. Rockefeller Cancer Institute

location_facility: Winship Cancer Institute Emory University

location_facility: Polyclinique de Limoges - Francois Chenieux

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

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

location_facility: University of Florida Health Jacksonville

location_facility: Rabin Medical Center - Hasharon Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana


acronym: BE HEARD EXT

lead_sponsor: UCB Biopharma SRL

summary: The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS)

title: A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

source: euctr

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

design_allocation: Non-Randomized

location_country:
Germany
Ireland
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Hungary
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Spain
Greece
Bulgaria


title: Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

summary: A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 as monotherapy in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who have progressed after receiving prior therapy for advanced/metastatic disease.

lead_sponsor: Merus N.V.

location_country:
Germany
Italy
Singapore
Netherlands
Belgium
United States
Korea, Republic of
Spain
France

location_facility: Istituto Nazionale dei Tumori Regina Elena

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: IOB Institute of Oncology - Hospital Quironsalud Barcelona

location_facility: Azienda Ospedaliero - Universitaria San Luigi Gonzaga

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Hospital General Universitario Gregorio Marañón

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

location_facility: CHU Hopitaux de Bordeaux - Hôpital Saint-André

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

location_facility: Hôpital Européen Georges Pompidou (HEGP)

location_facility: Fundación Instituto Valenciano de Oncología (IVO)

location_facility: Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

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

location_facility: Hospital Universitari i Politècnic La Fe


title: A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration

acronym: GALE

summary: This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
New Zealand
Israel
Argentina
United Kingdom
Australia
Brazil
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: Vision Research Center Eye Associates of NM

location_facility: Byers Eye Institute, Stanford University

location_facility: Radboud university medical center Oogheelkunde

location_facility: Retina Institute of California Medical Group

location_facility: Uni-medizin Gottingen Augenklinik 3.B1.261

location_facility: Retina Group of New England - New London

location_facility: ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Northwestern Feinberg School of Medicine

location_facility: Florida Eye Microsurgical Institute, Inc.

location_facility: Organizacion Medica de Investigacion (OMI)

location_facility: University of Utah - John A. Moran Center

location_facility: Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky

location_facility: Northern California Retina Vitreous Associates

location_facility: Charlotte Eye Ear Nose and Throat Associates, PS

location_facility: Vitreous Retina Macula Consultants of New York

location_facility: Centre Hospitalier Intercommunal de Creteil


title: Evaluation of the Efficacy of MaaT013 as Salvage Therapy in Acute GVHD Patients With Gastrointestinal Involvement, Refractory to Ruxolitinib; a Multi-center Open-label Phase III Trial.

acronym: ARES

summary: MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.

ipd_sharing: Undecided

lead_sponsor: MaaT Pharma

location_country: Germany Italy Austria Belgium Spain France

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Clinica Universidad de Navarra - Pamplona

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

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia

location_facility: Universitätsklinik Ulm - Oberen Eselsberg

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Centre Hospitalier Universitaire Amiens-Picardie - Site Sud

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Complejo Asistencial Universitario de Salamanca - Hospital Clínico


title: A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)

acronym: BRUIN CLL-321

summary: This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

lead_sponsor: Loxo Oncology, Inc.

sponsor_collaborators:
Loxo Oncology, Inc.
Eli Lilly and Company

location_country:
Germany
Ireland
Poland
Australia
Japan
Turkey
Croatia
Czechia
Canada
France
Hungary
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Oncology Dispensary #2 of Krasnodar Region

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: A.O.U. Citta' della Salute e della Scienza di Torino

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Istanbul University Istanbul Medicine Faculty

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Istituto di Ematologia-C.R.E.O. (Centro di Ricerche Emato-Oncologich)

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Clinica di Ematologia IOSI, Ospedale Bellinzona e Valli, Ente Ospedaliero Cantonale

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Blood Institute of the Chinese Academy of Medical science

location_facility: University of Kentucky Markey Cancer Center

location_facility: The Center for Cancer and Blood Disorders

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

location_facility: Southern Medical University Nanfang Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Division of Hematology, Dept. of Internal Medicine, University Hospital Centre Zagreb

location_facility: CHU De Grenoble Hopital Albert Michallon

location_facility: Xuanwu Hospital Capital Medical University

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

location_facility: ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

location_facility: Oddzial Hematologiczny, Specjalistyczny Szpital im. dra Sokołowskiego w Wałbrzychu

location_facility: Oncology-Hematology Associates of West Broward

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

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

location_facility: Hospital Universitario Infanta Leonor-INTERNAL MED

location_facility: Pole Regionalde Cancérologie(CHU de Poitiers)

location_facility: Cancer Center Office of Clinical Research

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Mercy Health-Paducah Medical Oncology and Hematology

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University

location_facility: Mitchell Cancer Institute -University of South Alabama

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Universitätsmedizin Mainz III. Medizinische Klinik und Poliklinik

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

location_facility: Complejo Hospitalario Universitario de Santiago de Compostel

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Cancer Specialists of North Florida -St Augustine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im.ks.B.Markiewicza

location_facility: University of Pecs 1st. Internalmedicin Clinic Dept

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Chu Nimes/Institut De Cancerologie Du Gard

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Federal State Budgetary Institution "Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medico-Biological Agency

location_facility: Carolina Blood and Cancer Care Associates

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

location_facility: Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo

location_facility: A.O.U. Policlinico G.Rodolico - S. Marco

location_facility: Tokai University Hospital- Isehara Campus

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Budgetary Healthcare Institution of Omsk Region "Clinical Oncology Dispensary"


acronym: ESCALADE

lead_sponsor: Acerta Pharma BV

summary: Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤75 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

sponsor_collaborators:
Acerta Pharma BV
AstraZeneca

title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤75 Years With Previously Untreated Non-GCB DLBCL

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:
Germany
Poland
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
United States
Ukraine
India
Belgium
China
Italy
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)

acronym: GREEN MEMORY

summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.

status: Suspended

lead_sponsor: Green Valley (Shanghai) Pharmaceuticals Co., Ltd.

location_country:
Poland
Hong Kong
Australia
Netherlands
United States
China
Taiwan
Czechia
Canada
France

location_facility: Jacksonville Center for Clinical Research

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Advanced Memory Research Institute of NJ, PC

location_facility: University of Nebraska Medical Center-Hematology/Oncology Section

location_facility: The Cognitive Research Center of New Jersey

location_facility: Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic

location_facility: Austin Health - Heidelberg Repatriation Hospital

status_simplified: Unknown


title: A Prospective, Non-interventional, Multinational, Observational Study With Isatuximab in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM)

acronym: IONA-MM

summary:
Primary Objective:

To assess the effectiveness, in terms of overall response rate (ORR) of isatuximab patients with RRMM in routine clinical practice, within 12 months

To assess other effectiveness parameters such as progression free survival (PFS), PFS rate (PFSR), duration of response (DoR), time to response, time and intent to first subsequent therapy, rate of very good partial response or better, rate of complete response (CR) or better of isatuximab patients with RRMM in routine clinical practice

To assess the profile of patients (demographic, disease characteristics, comorbidities and prior MM treatment history) who are treated with isatuximab in routine clinical practice

To describe safety of isatuximab in routine clinical practice (based on adverse event [AE] reporting)

To assess quality of life (QoL) using the European Organization for Research and Treatment of Cancer (EORTC) 30 item core questionnaire (QLQ C30) and the accompanying 20 item myeloma questionnaire module (QLQ MY20)

Secondary Objective:

Not applicable

study_type: Observational

time_perspective: Prospective

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

lead_sponsor: Sanofi

location_country:
Germany
Argentina
Japan
Kuwait
France
Hong Kong
Switzerland
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
United Arab Emirates
Saudi Arabia
Spain
Russian Federation

location_facility: Regional Cancer Care Associates, LLC - Freehold Division Site Number : 8400017

location_facility: Central Maine Medical Center Site Number : 8400031

location_facility: Comprehensive Hematology Oncology Site Number : 8400026

location_facility: Tri County Hematology & Oncology Associates, Inc Site Number : 8400012

location_facility: Renovatio Clinical Site Number : 8400004

location_facility: Central Care Cancer Center Site Number : 8400019

location_facility: Puerto Rico Medical Research Center, LLC Site Number : 8400001

location_facility: University of California San Francisco (PARENT) Site Number : 8400009

location_facility: Regional Cancer Care Associates - Little Silver Division Site Number : 8400018

location_facility: Novant Health Forsyth Medical Center Site Number : 8400028

location_facility: Central Care Cancer Center Site Number : 8400006

location_facility: University of Arkansas Medical Sciences Site Number : 8400021

location_facility: Prairie Lakes Health Care System, Inc Site Number : 8400002

location_facility: Michigan Center of Medical Research Site Number : 8400010

location_facility: Auxilio Mutuo Cancer Center Site Number : 8400029

location_facility: St. Joseph Heritage Healthcare Site Number : 8400008

location_facility: Prisma Health - Eastside Office Site Number : 8400011

location_facility: Regional Cancer Care Associates Site Number : 8400024

location_facility: Charleston Hematology Oncology Associates, PA Site Number : 8400020

location_facility: Watson Clinic Cancer and Research Center Site Number : 8400023

location_facility: Millennium Oncology Site Number : 8400025

location_facility: Holy Cross Hospital Site Number : 8400030

location_facility: MD Anderson Cancer Center Site Number : 8400013

location_facility: Hematology & Oncology Associates Site Number : 8400015


title: Randomized Placebo-controlled Double-blinded Study of the Effect of TOTUM-63 on Glucose and Lipid Homeostasis in Subjects With Dysglycemia

acronym: REVERSE-IT

summary: This clinical study aims to assess the efficacy of TOTUM-63, a mix of 5 plant extracts, consumed at the daily regimen of three times per day on glucose and lipid homeostasis in dysglycemic subjects. The hypothesis is that TOTUM-63, consumed 3 times per day, is superior to placebo for decrease of fasting plasma glucose (FPG) concentration after 24 weeks of consumption.

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Valbiotis

sponsor_collaborators:
Valbiotis
Biofortis Mérieux NutriSciences

location_country: Germany Italy Poland Hungary Romania Bulgaria France

location_facility: Diagnostic Consultative Center "ALEXANDROVSKA"

location_facility: Unité d'Investigation Clinique Biofortis Mérieux NutriSciences

location_facility: Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

location_facility: Diagnostic-consultative center 7 EOOD, Plovdiv

location_facility: Gemeinschaftspraxis Dr. Med C. Klein/J Minnich

location_facility: Unité de Recherche Clinique en Immunologie Lyon Sud

location_facility: University Multiprofile Hospital for active treatment "Alexandrovska" EAD Clinic of Endocrinology and metabolic diseases

location_facility: MHAT Sveta Karidad, First department of Internal Diseases

location_facility: Azienda Ospedaliera Universitaria "Mater Domini"

location_facility: Zentrum für Klinische Ernährung Stuttgart

location_facility: Ambulatory for IPSOC in Endocrynology and Metabolic Diseases ENDO MED-CONSULT EOOD

location_facility: 4th Multiprofile Hospital for active treatment - EAD, Internal Diseases Departement

intervention_type: Dietary Supplement

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing SAR442168 to Placebo in Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

acronym: HERCULES

summary:
Primary Objective:

To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS

Secondary Objective:

To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

location_country:
Finland
Germany
Poland
Argentina
Australia
Japan
Turkey
Czechia
Canada
France
Belarus
Lithuania
Portugal
Hungary
Denmark
United States
Ukraine
India
Romania
Belgium
China
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: University Of Vermont College Of Medicine-Site Number:8400130

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

location_facility: Advanced Neuroscience Center-Site Number:8400035

location_facility: Lou Ruvo Center for Brain Health-Site Number:8400117

location_facility: Collaborative Neuroscience Research-Site Number:8400045

location_facility: Missouri Baptist Medical Center-Site Number:8400019

location_facility: Optimed Research, LTD-Site Number:8400147

location_facility: University of Colorado-Site Number:8400012

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

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

location_facility: Icahn School of Medicine at Mount Sinai (Department of Endoc-Site Number:8400038

location_facility: University Hospitals CMC-Site Number:8400083

location_facility: Meridian Clinical Research-Site Number:8400003

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

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

location_facility: Medical College of Wisconsin-Site Number:8400028

location_facility: Mountain View Clinical Research-Site Number:8400024

location_facility: Jefferson Neurology Associates-Site Number:8400016

location_facility: Advanced Neurosciences Research-Site Number:8400025

location_facility: South Florida Neurology Associates-Site Number:8400029

location_facility: Aqualane Clinical Research-Site Number:8400027

location_facility: Wayne State University-Site Number:8400046

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

location_facility: Neurology Associates, PA-Site Number:8400004

location_facility: University of Alabama MS Center-Site Number:8400013

location_facility: Providence Multiple Sclerosis Center-Site Number:8400020

location_facility: Regina Berkovich, MD, PhD-Site Number:8400059

location_facility: Minneapolis Clinic of Neurology-Site Number:8400051

location_facility: University of San Francisco, Sandler Neurosciences Center-Site Number:8400137

location_facility: Neurology Clinic, PC-Site Number:8400087

location_facility: Arcadia Neurology Center-Site Number:8400070

location_facility: The Memorial Hospital-Site Number:8400033

location_facility: Multiple Sclerosis Center-Site Number:8400143

location_facility: University of New Mexico-Site Number:8400032

location_facility: University of South Florida-Site Number:8400006

location_facility: Consultants In Neurology-Site Number:8400011

location_facility: Perelman Center for Advanced Medicine-Site Number:8400142

location_facility: Axiom Clinical Research of Florida-Site Number:8400001

location_facility: University of Kansas Medical Center-Site Number:8400023

location_facility: Tufts Medical Center-Site Number:8400072

location_facility: Neurology Associates of Stony Brook-Site Number:8400042

location_facility: Baylor College of Medicine-Site Number:8400136

location_facility: University of Massachusetts-Site Number:8400014


acronym: CREST

lead_sponsor: Pfizer

summary:
The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).

In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.

One group is given sasanlimab and BCG at the study clinic.
The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
The third group is given BCG only and will not receive sasanlimab.

In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.

- Both groups will be given sasanlimab at the study clinic.

On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Premier Medical Group of the Hudson Valley PC

location_facility: Kaluga Regional Clinical Oncology Center

location_facility: Vancouver Prostate Centre at the Vancouver General Hospital

location_facility: University of California Irvine Medical Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean

location_facility: Fujian Medical University Affiliated First Hospital

location_facility: UO Oncologia, ASST di Cremona - Istituti Ospitalieri - Ospedale di Cremona

location_facility: Kingston Health Sciences Centre -- Hotel Dieu Hospital

location_facility: Kingston Health Sciences Centre - Kingston General Hospital

location_facility: DuPage Medical Group Ambulatory Surgery Center

location_facility: Regional Urology Oncology & Radiation Center

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Bashkortostan Republic

location_facility: Associated Medical Professionals of New York, PLLC

location_facility: Budgetary Healthcare Institution of Vologda region "Vologda Regional Clinical Hospital"

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: Montefiore Medical Center - Montefiore Medical Park

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: University Health Network - Toronto General Hospital

location_facility: State Budgetary Healthcare Institution "Leningrad Regional Clinical Oncology Dispensary"

location_facility: Hospital Duran i Reynals- ICO L'Hospitalet

location_facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)

location_facility: State Budgetary Institution of Healthcare of the Republic of Mordovia

location_facility: McMaster Institute of Urology/St Joseph's Healthcare Hamilton

location_facility: Groupe Vivalto Sante - Clinique Pasteur-Lanroze- CFRO

location_facility: IRCCS Ospedale San Raffaele, URI (Urological Research Institute)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: P.A. Hertsen Moscow Oncology Research Center- branch of the National Medical Research

location_facility: A.Tsyb Medical Research Radiological Center of the Ministry of Health of the Russian Federation

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Urological Associates of Southern Arizona, P.C .

location_facility: Regional Budgetary Healthcare Institution "Ivanovo Regional Oncology Dispensary"

location_facility: Second Affiliated Hospital of Suzhou University

location_facility: BHI of Omsk region "Clinical Oncological Dispensary"

location_facility: Hotel-Dieu de Quebec - CHU de Quebec - Universite Laval

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: NYU Langone Medical Center (Tisch Hospital)

location_facility: AO Azienda Ospedaliera Ordine Mauriziano Di Torino

location_facility: SBHI YaR Regional clinical oncology hospital

location_facility: University Health Network - Princess Margaret Cancer Centre

location_facility: Ochsner LSU Health Shreveport - Regional Urology

location_facility: ASST Sette Laghi Ospedale di Circolo Fondazione Macchi

location_facility: Ospedale Area Aretina Nord - UOC Oncologia Medica

location_facility: Private Medical Institution "Euromedservice"

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Seoul National University Bundang Hospital

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

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Klinikum der Goethe-Universitaet Frankfurt

location_facility: State Budgetary Institution of Ryazan Region "Regional Clinical Oncology Center"

location_facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

location_facility: IRCCS Azienda Ospedaliera Universitaria Policlinico San Martino Urologia

location_facility: Humanitas Istituto Clinico Catanese S.p.A - U.O. Oncologia Medica

location_facility: Ospedale Generale Provinciale di Macerata - UOC Oncologia

location_facility: Barts Health NHS Trust, St Bartholomew's Hospital

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: Joint-Stock Company "North-Western Centre of Evidence-Based Medicine" ("NWCoEBM" JSC)

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Montefiore Medical Center - Oncology Investigational Services

location_facility: Polyclinique de Limoges Site Emailleurs-Colombier

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Urologiczne Sp. z o.o.

location_facility: Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Spolka Komandytowa

location_facility: West China Hospital of Sichuan University

location_facility: First Affiliated Hospital of Xi 'an Jiaotong University

location_facility: Federal State Budgetary Healthcare Institution Saint - Petersburg

location_facility: UO Oncologia Medica IRCCS Istituto Tumori "Giovanni Paolo II"

location_facility: Sulpizio Cardiovascular Center at UC San Diego Health

location_facility: Federal Budgetary Institution of Healthcare "Privolzhsky District Medical Center of the Federal

location_facility: Hamilton Regional Laboratory Medicine Program

location_facility: Urological Associates of Southern Arizona P.C.

location_facility: Kyungpook National University Chilgok Hospital

location_facility: IRCSS Istituto Clinico Humanitas - U.O. Oncologia Medica

title: A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Japan
Belgium
United States
China
Korea, Republic of
Spain
Canada
Russian Federation
France


title: A Prospective, Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Transcatheter Aortic Valve Implantation in Female Patients Who Have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement

acronym: RHEIA

summary: Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.

primary_purpose: Other

ReferenceType: derived

ReferenceCitation: Eltchaninoff H, Bonaros N, Prendergast B, Nietlispach F, Vasa-Nicotera M, Chieffo A, Pibarot P, Bramlage P, Sykorova L, Kurucova J, Bax JJ, Windecker S, Dumonteil N, Tchetche D. Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial). Am Heart J. 2020 Oct;228:27-35. doi: 10.1016/j.ahj.2020.06.016. Epub 2020 Jun 30.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

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

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

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Optimapharm

sponsor_collaborators:
Optimapharm
Edwards Lifesciences

location_country:
Finland
Germany
Cyprus
Ireland
Italy
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Czechia
France

location_facility: Les Hopitaux Universitaires de Strasbourg - Nouvel Hôpital Civil

location_facility: Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco"

location_facility: Universitätsklinik der Ruhr-Universität Bochum

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: CHU de Nantes - Hôpital Guillaume et René Laënnec

location_facility: Universitätsklinikum St. Pölten - Lilienfeld

location_facility: Oxford University Hospitals - John Radcliffe hospital

location_facility: CHU Clermont-Ferrand - Hôpital Gabriel Montpied

location_facility: IKEM (Institut Klinické a Experimentální Medicíny)

location_facility: CHU de Bordeaux - Hôpital cardiologique du Haut-Lévêqu

intervention_type: Procedure


summary:
Primary Objectives:

Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cut-off date for each given analysis (progression free survival [PFS] and overall survival [OS])
Study success is defined either on PFS or OS
The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous non-small-cell lung cancer (NSCLC) expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI)
The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 greater than or equal to 2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.

Secondary Objectives:

To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel
To compare the health-related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel
To evaluate the safety of tusamitamab ravtansine compared to docetaxel
To assess the duration of response (DOR) of tusamitamab ravtansine as compared with docetaxel

location_facility: Renovatio Clinical Site Number : 8400013

location_facility: A Beneficencia Portuguesa de Sao Paulo - Hospital Beneficencia Portuguesa - BP Mirante Site Number : 0760024

location_facility: Roswell Park Cancer Institute Site Number : 8400011

location_facility: Hospital Sao Lucas da PUCRS Site Number : 0760005

location_facility: Arizona Oncology Associates Site Number : 8400024

location_facility: IEP - Instituto de Ensino e Pesquisa Sao Lucas Site Number : 0760010

location_facility: Bon Secours St. Francis Medical Center Site Number : 8400035

location_facility: Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760007

location_facility: Cancer Treatment Center of America(CTCA) - Southeastern Site Number : 8400015

location_facility: Centro Regional Integrado De Oncologia - CRIO Site Number : 0760002

location_facility: Clínica de Oncologia Reichow Site Number : 0760023

location_facility: National Jewish Health Site Number : 8400033

location_facility: Medical College of Wisconsin Site Number : 8400006

location_facility: Ca & Hem Center Of W Michigan Site Number : 8400016

location_facility: Renovatio Clinical Site Number : 8400032

location_facility: Lankenau Hospital Cancer Center Site Number : 8400017

location_facility: Hospital Alemao Oswaldo Cruz Site Number : 0760022

location_facility: Thompson Cancer Survival Center Site Number : 8400038

location_facility: Florida Cancer Specialists North Division Site Number : 8400019

location_facility: Tennessee Oncology Nashville Site Number : 8400003

location_facility: Hospital Mae de Deus Site Number : 0760012

location_facility: Centro Avancado de Oncologia CECAN - Liga Contra o Cancer Site Number : 0760026

location_facility: Texas Oncology, PA Site Number : 8400030

location_facility: Florida Cancer Specialists South Division Site Number : 8400020

location_facility: OC ONCOCLINICAS BOTAFOGO Site Number : 0760025

location_facility: Hospital Sirio Libanes Site Number : 0760018

location_facility: Comprehensive Blood and Cancer Center Site Number : 8400007

location_facility: Instituto De Oncologia Parana Site Number : 0760008

location_facility: Hospital de Base Sao Jose do Rio Preto Site Number : 0760001

title: Randomized, Open-label, Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated, Metastatic Nonsquamous, Non-small-cell Lung Cancer Patients With CEACAM5-positive Tumors

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Lithuania
Portugal
Hungary
United States
India
Romania
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Israel


type: Other Grant/Funding Number

title: A Randomized Phase 3 Multicenter Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

summary:
The purpose of this study is to compare the effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group.

Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.

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

lead_sponsor: Takeda

location_country:
Germany
Australia
Japan
Turkey
Canada
France
Portugal
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Centro Hospitalar do Porto Hospital de Santo Antonio

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: University College London Hospitals (UCLH)

location_facility: Beth Israel Deaconess Medical Center - 330 Brookline Ave

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: National Hospital Organization Yamaguchi-Ube Medical Center

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Beijing Chest Hospital, Capital Medical Univerity

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l - PPDS

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

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Municipal Non-profit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC

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

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Harbin Medical University Tumor Hospital

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Malteser Krankenhaus St. Franziskus-Hospital

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

location_facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital General Universitario de Alicante

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Chonnam National University Hwasun Hospital

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR

location_facility: National Taiwan University Hospital - YunLin Branch

location_facility: ICO lHospitalet Hospital Duran i Reynals

location_facility: Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente

location_facility: Baskent University Medical Faculty Adana Practice and Research Center

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Private Enterprise Private Manufacturing Company Acinus


title: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

acronym: CheckMate 9DW

summary: The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Hong Kong
Switzerland
United States
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility:
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title: Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

summary:
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery.

Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

lead_sponsor: Seagen Inc.

location_country:
Germany
Australia
Japan
Canada
France
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Israel

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: CHI Saint Joseph Medical Group Cancer Care Center

location_facility: University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

location_facility: Hopital Saint-Louis / Service d'Hematologie

location_facility: University of Ottawa / Ottawa General Hospital

location_facility: Florida Cancer Specialists - East West Palm Beach, FL (SCRI)

location_facility: Hiroshima City Hiroshima Citizens Hospital

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

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Institute of Oncology of Southern Switzerland

location_facility: Hospital Center Regional University Morvan De Brest

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Kapi'olani Medical Center for Women and Children

location_facility: Florida Cancer Specialists - North Region

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval

location_facility: University of Texas Southwestern Medical Center

location_facility: Saint Francis Hospital / Bon Secours - Virginia

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: University of California Irvine - Newport

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: The Center for Cancer and Blood Disorders: Fortworth

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

location_facility: Grand Hôpital de Charleroi - Saint-Joseph

location_facility: The Affiliated Hospital of Guangdong Medical University

location_facility: Xi'An International Medical Center Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Shengjing Hospital of China Medical University

location_facility: Hakuaikai Sagara Hospital/Breast Surgery

location_facility: University of Colorado Health Memorial Hospital

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

location_facility: SCL Health Good Samaritan Medical Center Cancer Centers of Colorado

location_facility: University of Pennsylvania / Perelman Center for Advanced Medicine

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care

location_facility: Kaiser Permanente Medical Center Northern California

location_facility: Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo FPO - IRCCS

location_facility: Lombardi Cancer Center / Georgetown University Medical Center

location_facility: Cancer Centre of Southeastern Ontario At Kingston General Hospital

location_facility: Saint Barnabas Medical Center Cancer Center

location_facility: Seconda Università degli Studi di Napoli, AOU

location_facility: Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris

location_facility: Goteborgs Universitet - Sahlgrenska Akademin - Institutionen For Kliniska Vetenskaper (Institute Of Clinical Sciences)

location_facility: Ironwood Cancer & Research Centers - Chandler

location_facility: Tennessee Oncology-Nashville/Sarah Cannon Research Institute

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Ft Wayne Medical Oncology and Hematology, Inc TRIO

location_facility: Chao Family Comprehensive Cancer Center University of California Irvine

location_facility: Florida Cancer Specialists - South Region

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: National University Cancer Institute, Singapore

location_facility: Seoul National University Bundang Hospital

location_facility: Kliniken Essen-Mitte - Evang. Huyssens-Stiftung

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: University Hospital Basel - Brustzentrum

location_facility: Huntsman Cancer Institute/University of Utah

location_facility: Texas Oncology - Methodist Dallas Cancer Center

location_facility: UCLA Department of Medicine - Hematology & Oncology

location_facility: Cancer Treatment Centers of America / Eastern Regional Medical Center

location_facility: California Cancer Associates for Research and Excellence Inc (cCARE)

location_facility: Gulou Hospital Affiliated to Nanjing University Medical College

location_facility: Centre de Lutte contre le Cancer - François Baclesse

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Center of Women and Children Hospital of Guangdong Province

location_facility: The Royal Marsden NHS Foundation Trust (RM)

location_facility: First Affiliated Hospital of Zhejiang University

location_facility: North Mississippi Medical Center Hematology Oncology - Tupelo

location_facility: LKH Salzburg, Universitatsklinikum der PMU

location_facility: Klinikum Rechts der Isar der Technischen Universitaet Muenchen

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Torrance Memorial Physician Network - TRIO

location_facility: University of Alberta / Cross Cancer Institute

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Brig Center for Cancer Care and Survivorship

location_facility: Helen F. Graham Cancer Center / Christiana Care Health Systems

location_facility: University of South Alabama - Mitchell Cancer Institute

location_facility: Skanes University Hospital - Universitetssjukhus

location_facility: InVO- Institut fUr Versorgungsforschung in der onkologie GbR

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Illinois Cancer Specialists - Arlington Heights

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: Tianjin Medical University - Cancer Institute & Hospital

location_facility: University of Colorado Hospital / University of Colorado


lead_sponsor: Eli Lilly and Company

summary: The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

location_facility: Tianjin Medical University General Hospital

location_facility: L2IP - Instituto de Pesquisas Clinicas Ltda.

location_facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: University of Mississippi School of Medicine

location_facility: Paediatric Clinical Research Facility Royal Hospital for Children and Young People

location_facility: Institut Klinicke a Experimentalni Mediciny

location_facility: The First People's Hospital of Changzhou

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: Woodholme Gastroenterology Associates - Glen Burnie

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul

location_facility: Velocity Clinical Research/Gut Whisperer

location_facility: Advanced Clinical Research-Spokane Gastroenterology

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: NYU Langone Long Island Clinical Research Associates

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

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: University of Texas Medical Branch at Galveston

location_facility: Spitalul Universitar de Urgență București

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: PanAmerican Clinical Research S.A.de C.V. Guadalajara

location_facility: State Scientific Centre of Coloproctology

location_facility: Hospital Universitario Central de Asturias

location_facility: Shanghai Jiaotong University School of Medicine Ruijin Hospital

location_facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

location_facility: HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: International Institute of Clinical Trials LLC

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen

location_facility: Konya Necmettin Erbakan Gastroenterology

location_facility: Synexus North East Clinical Research Centre

location_facility: Ruby Hall Clinic and Grant Medical Foundation

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

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: West Central Gastroenterology d/b/a Gastro Florida

location_facility: Synexus Midlands Clinical Research Center

location_facility: Affiliated Hospital of Jiangsu University

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

location_facility: Medical and Sanitary Division of Severstal

location_facility: Clinical Trials Center of Medical Institute

location_facility: First affiliated Hospital of Sun Yat-Sen University

location_facility: Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV

location_facility: Nickalus Children's Hospital Research Institute

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC

location_facility: Endomedix Diagnosztikai Központ - Miskolc

location_facility: PanAmerican Clinical Research Mexico S.A. de C.V.

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Shengjing Hospital of China Medical University

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

location_facility: HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará

location_facility: The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university

location_facility: Kharkiv Regional Council Regional Clinical Hospital

location_facility: The Second Affiliated Hospital of Soochow University

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

location_facility: Marmara University Pendik Research and Training Hospital

location_facility: Synexus Manchester Clinical Research Centre

location_facility: GastroIntestinal Biosciences Clinical Trials

location_facility: Lovelace Scientific Resources - Albuquerque

location_facility: Nizhny Novgorod Regional Hospital N.A. Semashko

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual

location_facility: Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

location_facility: Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi

location_facility: Azienda ospedaliero-universitaria Mater Domini

location_facility: Jiangsu Province Hospital of Chinese Medicine

location_facility: Research Associates of South Florida, LLC

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: Caguas Gastroenterology and Hepatology Center, LLC

location_facility: Ivano-Frankivsk State Medical University

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Inonu Universitesi Turgut Ozal Tıp Merkezi

location_facility: NonState Healthcare Institution Central Clinical Hospital

location_facility: USPA Advance Concept Medical Research Group LLC.

location_facility: The First Hospital Affiliated to AMU (Southwest Hospital)

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Southern Therapy and Advanced Research (STAR) LLC

location_facility: Gastroenterology Consultants of Clearwater

location_facility: University of Texas Health Services Center - Houston

location_facility: Tokyo Medical and Dental University Hospital

location_facility: MGG Group, Inc.., Co., Chevy Chase Clinical Research

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

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

location_facility: SR Kalla Memorial Gastro & General Hospital

location_facility: Xiangya Hospital Central South University

location_facility: Eskisehir Osmangazi University Gastroenterology

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli

location_facility: Medical Center of Limited Liability Company "Medical Center "Consilium Medical"

location_facility: University Hospitals Cleveland Medical Center

location_facility: MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance

location_facility: Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Practice Dr.med. Denger and Dr.med. Pfitzner

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

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

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Krankenhaus der Barmherzigen Schwestern Wien

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: St. Marienkrankenhaus-Medizinische Klinik I

location_facility: Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway

location_facility: Hopital de Hautepierre - Service d'Hépatogastroentérolgie

location_facility: Saint-Petersburg City Hospital of Saint Elizabeth

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Postgraduate Institute of Medical Education & Research

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: National Center for Global Health and Medicine

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases

location_facility: University Medical Center "Bezanijska kosa"

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin

location_facility: West China Hospital of Sichuan University

location_facility: Gastroenterologische Praxis Balsiger, Seibold & Partner

location_facility: Università degli Studi c/o Spedali Civili

location_facility: Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin

location_facility: Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech

location_facility: Private Practice - Dr. Korczowski Bartosz

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: University of Alabama-The Kirklin Clinic

location_facility: Associacao Paranaense de Cultura - PUCPR

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: The First Hospital of China Medical University

location_facility: Università di Cagliari - Presidio Policlinico Monserrato

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Multidisciplinary Medical Clinic "Anthurium"

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Gastroenterology and internal medicine research institute

location_facility: Oblastni nemocnice Nachod-Endoskopicke centrum

location_facility: Clinical Center Kragujevac Gastroenterohepatology Clinic

location_facility: Gujarat Hospital - Gastro and Vascular Centre

location_facility: Academician I.P. Pavlov First St-Petersburg State Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Azienda Ospedaliera Policlinico Consorziale

location_facility: Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda

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

location_facility: National Hospital Organization Fukuyama Medical Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: The First People's Hospital of Yunnan Province

location_facility: Synexus Clinical Research GmbH-Leipzig Research Centre

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Azienda Ospedaliera Santa Maria Della Misericordia

location_facility: Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine

location_facility: National Hospital Organization Hirosaki General Medical Center

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

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

location_facility: Northshore Gastroenterology Research, LLC

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: Acibadem Universitesi - Acibadem Kozyatagi Hastanesi

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Scientific Centre of Reconstructive and Restorative Surgery

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Advanced Biomedical Research of America - South Eastern Avenue

location_facility: CHU de Poitiers- Service d'Hépato-gastro-entérologie,

location_facility: Gastroenterology Associates of the Piedmont

location_facility: RCI Chernivtsi Regional Clinical Hospital

location_facility: CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Hacettepe University Faculty of Medicine

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

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
Argentina
Australia
Brazil
Japan
Turkey
Croatia
Czechia
Canada
Serbia
France
Lithuania
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
India
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


summary: The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Weill Medical College of Cornell University

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Albert Schweitzer ziekenhuis-lokatie Dordwijk

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

location_facility: Universita Degli Studi di Roma 'Tor Vergata'

location_facility: Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

location_facility: Asst Ovest Milanese - Ospedale Di Legnano

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Centre Hospitalier Lyon-Sud Service d'hematologie

location_facility: Oncology Institute of Hope and Innovation

location_facility: Washington University School of Medicine

location_facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

location_facility: Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Karmanos Cancer Institute - Wayne State University

location_facility: Universidade Federal de Goias - Hospital das Clinicas da UFG

location_facility: Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux

location_facility: Praxisklinik für Haematologie und Onkologie Koblenz

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Hopitaux Universitaires Est Parisien Hopital Saint Antoine

location_facility: University of Athens - Evaggelismos Hospital (Evangelismos Hospital)

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

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

status: Terminated

title: A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment

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
Poland
Denmark
Brazil
Netherlands
Belgium
United States
Spain
Greece
Canada
Russian Federation
France


acronym: COAST

lead_sponsor: MedImmune LLC

summary: The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

ReferenceCitation: Herbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Oct 10;40(29):3383-3393. doi: 10.1200/JCO.22.00227. Epub 2022 Apr 22.

oa_host_type: publisher

evidence: open (via page says license)

repositories_concat: closed

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

location_country:
Italy
Poland
Portugal
Hong Kong
United States
Spain
Taiwan
Canada
France