acronym: ELATIVE

lead_sponsor: Ipsen

summary: The main objective of the study is to evaluate the effect of daily oral administration of 80mg elafibranor on cholestasis (impairment of bile formation and/or bile accumulation) in patients with PBC and inadequate response or intolerance to Ursodeoxycholic Acid (UCDA). In the DB period, patients will be randomized in a 2:1 ratio to receive Elafibranor 80 mg or placebo, once daily.

location_facility: Texas Digestive Disease Consultants dba GI Alliance

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: The New York-Presbyterian Hospital, David H. Koch Center

location_facility: Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology

location_facility: Medical University of South Carolina- College of Medicine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.

location_facility: University of Colorado Denver and Hospital

location_facility: NYU Langone Health / NYU Grossman School of Medicine

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Frimley Health NHS Foundation Trust - Frimley Park Hospital

location_facility: University Hospitals Cleveland Medical Center

location_facility: Groote Schuur Hospital, University of Cape Town - Clinical Research Centre

location_facility: St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation

location_facility: Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads

location_facility: King's College Hospital. King's College NHS Foundation Trust

location_facility: Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Virginia Commonwealth University Clinical Research Services Unit (CRSU)

location_facility: University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP

location_facility: Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie

location_facility: Yale School of Medicine, Digestive Diseases

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital

location_facility: ASST Monza - Ospedale San Gerardo, Gastroenterologia

location_facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica

location_facility: Centro de Investigaciones Clinicas (CIC)

location_facility: Intermountain Medical Center - Transplant Services

location_facility: Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary

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

location_facility: Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre

location_facility: Carolinas Centre for Liver disease/ Atrium Health

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: University of California, Davis Medical Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale

location_facility: Centro de Investigacion Clinica Universidad Catolica CICUC

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond

location_facility: Belfast Health and Social Care Trust-Royal Victoria Hospital

location_facility: Hospital Universitario Puerta de Hierro -Madrid

location_facility: The University of Texas Southwestern Medical Center-IDS Aston Pharmacy

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali

location_facility: Center for Gastroenterology and Hepatology (GHZ) Kiel

location_facility: Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia

location_facility: Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center

location_facility: University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)

location_facility: Plymouth Hospitals NHS Trust, Derriford Hospital

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: CHU Grenoble Alpes - Hôpital Albert Michallon

location_facility: Encore Borland-Groover Clinical Research

location_facility: Beth Israel Deaconess Medical Center (BIDMC)

location_facility: Columbia University Medical Center - Center for Liver Disease and Transplantation

location_facility: Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)

title: A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid

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, annotated 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 study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_country:
Germany
Italy
United Kingdom
Argentina
Brazil
Switzerland
Belgium
United States
Spain
South Africa
Turkey
Chile
Canada
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The purpose of this study was to assess the preliminary antitumor activity, safety and tolerability of tepotinib in combination with cetuximab in participants with RAS/BRAF wild-type left-sided Metastatic Colorectal Cancer (mCRC) having acquired resistance to anti-epidermal growth factor receptor (EGFR) antibody targeted therapy due to mesenchymal epithelial transition (MET) amplification.

location_facility: SAHI Republican Clinical Oncology Dispensary

location_facility: Fondazione IRCCS - Istituto Tumori Milano

location_facility: University of California, Los Angeles (UCLA)

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: VHIO Valle de Hebron Instituto de Oncologia

location_facility: Istituto Nazionale Tumori, Fondazione G. Pascale Napoli

location_facility: Georgetown Lombardi Comprehensive Cancer Center

location_facility: Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chiara

location_facility: Arkangelsk Clinical Oncological Dyspensary

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Dept. of Oncology Faculty Hospital Motol

location_facility: Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: FSBI "National Medical Research Center of Oncology n.a. N.N. Blokhina" of the MoH of the RF

location_facility: Russian Cancer research center n.a. N.N. Blokhin

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: Foundation IRCCS Casa Sollievo della Sofferenza

status: Terminated

title: A Phase II Single-Arm Study to Investigate Tepotinib Combined With Cetuximab in RAS/BRAF Wild-Type Left-Sided mCRC Patients Having Acquired Resistance to Anti-EGFR Antibody Targeting Therapy Due to MET Amplification (PERSPECTIVE)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

study_completion_date_type: Actual

location_country:
Italy
United Kingdom
Belgium
United States
Spain
Czechia
Russian Federation
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis

acronym: NAVIGATE

summary: This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients with nonalcoholic steatohepatitis (NASH) cirrhosis and clinical signs of portal hypertension but without esophageal varices at baseline.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

primary_purpose: Prevention

ipd_sharing: No

lead_sponsor: Galectin Therapeutics Inc.

location_country:
Germany
Poland
Israel
Argentina
United Kingdom
Australia
Mexico
Belgium
United States
Korea, Republic of
Spain
Chile
Canada
Puerto Rico
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Medyczny Katedra i Klinika Chorób Zakaźnych, Chorób Wątroby i Nabytych Niedoborów Odpornościowych

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

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

location_facility: The Ohio State University Wexner Medical Center

location_facility: Bon Secours Liver Institute of Virginia - Newport News

location_facility: Clinique Universitaire De Bruxelles Hôpital Erasme VZW

location_facility: University of Virginia School of Medicine

location_facility: Mercy Medical Center - The Institute for Digestive Health and Liver Disease

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Bon Secours Liver Institute of Virginia - Richmond

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: University of California San Diego Medical Center -La Jolla Multi-Specialty Clinics- Perlman Offices

location_facility: University of Calgary - Heritage Medical Research Clinic - Foothills Hospital Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Integrity Clinical Research, LLC (ICR SITES) - Doral

location_facility: CICPA Centro de Investigación Clinica del Pacifico

location_facility: Gastro One - GI Diagnostic and Therapeutic Endoscopy Center - 1310 Wolf Park

location_facility: Pioneer Research Solutions Inc - Houston - Stancliff Rd

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: The Chaim Sheba Medical Center - The Center for Liver Diseases

location_facility: Medical University of South Carolina (MUSC)

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada SC

location_facility: Gastroenterology Associates of Fredericksburg

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: King's College Hospital NHS Foundation Trust

location_facility: University of Cincinnati Physicians Company, LLC

location_facility: Southern Therapy and Advanced Research (STAR) - Jackson

location_facility: Centro Especializado en Diabetes, Obesidad y Pevencion de enfermedades Cadiovasculares SC.

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Investigacion Biomedica para el desarrollo de farmacos SA de CV

location_facility: SP CSK im Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Groupe sante CHC - Clinique du MontLegia

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: University of Utah Health Care - UUHC - Kidney & Liver Clinic

location_facility: MEDIVEST Centro de Investigacion integral

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: Centro de Investigación Medica de Aguascalientes

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: The University of Nottingham - Nottingham Digestive Diseases Centre Biomedical Research Unit

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases

location_facility: Yonsei University, Wonju Severance Christian Hospital

location_facility: NewYork-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: University Diabetes & Endocrine Consultants

location_facility: Baylor College of Medicine - Baylor Clinic - Abdominal Transplant & Liver Disease Clinic

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University of Louisville Physicians - Cardiovascular Medicine Physicians Outpatient Center

location_facility: The Jefferson Digestive Health Institute - Thomas Jefferson University

location_facility: Henry Ford Health System - Hemophilia and Thrombosis Treatment Center

location_facility: Digestive Research Alliance of Michiana, LLC

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez Servicio de Gastroenterología

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: East Tennessee Research Institute - Gastrointestinal Associates of Northeast Tennessee, P.C.

location_facility: CEMDEC SA de CV Centro Mexicano de Desarrollo de Estudios Clinicos

status_simplified: Ongoing


acronym: PANAMO

lead_sponsor: InflaRx GmbH

summary:
Phase II & Phase III:

This is a pragmatic, adaptive, randomized, multicenter phase II/III study evaluating IFX-1 for the treatment of COVID-19 related severe pneumonia. The study consists of two parts: Phase II, an open-label, randomized, 2-arm phase evaluating best supportive care (BSC) + IFX-1 (Arm A) and BSC alone (Arm B); and Phase III, a double-blind, placebo-controlled, randomized phase comparing standard of care (SOC) + IFX-1 (Arm A) versus SOC + placebo-to-match (Arm B)

ReferenceType: derived

ReferenceCitation: Vlaar APJ, Witzenrath M, van Paassen P, Heunks LMA, Mourvillier B, de Bruin S, Lim EHT, Brouwer MC, Tuinman PR, Saraiva JFK, Marx G, Lobo SM, Boldo R, Simon-Campos JA, Cornet AD, Grebenyuk A, Engelbrecht JM, Mukansi M, Jorens PG, Zerbib R, Ruckinger S, Pilz K, Guo R, van de Beek D, Riedemann NC; PANAMO study group. Anti-C5a antibody (vilobelimab) therapy for critically ill, invasively mechanically ventilated patients with COVID-19 (PANAMO): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2022 Dec;10(12):1137-1146. doi: 10.1016/S2213-2600(22)00297-1. Epub 2022 Sep 7.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

version: publishedVersion

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Vlaar APJ, Lim EHT, de Bruin S, Ruckinger S, Pilz K, Brouwer MC, Guo RF, Heunks LMA, Busch MH, van Paassen P, Riedemann NC, van de Beek D. The anti-C5a antibody vilobelimab efficiently inhibits C5a in patients with severe COVID-19. Clin Transl Sci. 2022 Apr;15(4):854-858. doi: 10.1111/cts.13213. Epub 2022 Jan 14.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Wiley

ReferenceCitation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

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

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk;pure.eur.nl

ReferenceCitation: Vlaar APJ, de Bruin S, Busch M, Timmermans SAMEG, van Zeggeren IE, Koning R, Ter Horst L, Bulle EB, van Baarle FEHP, van de Poll MCG, Kemper EM, van der Horst ICC, Schultz MJ, Horn J, Paulus F, Bos LD, Wiersinga WJ, Witzenrath M, Rueckinger S, Pilz K, Brouwer MC, Guo RF, Heunks L, van Paassen P, Riedemann NC, van de Beek D. Anti-C5a antibody IFX-1 (vilobelimab) treatment versus best supportive care for patients with severe COVID-19 (PANAMO): an exploratory, open-label, phase 2 randomised controlled trial. Lancet Rheumatol. 2020 Dec;2(12):e764-e773. doi: 10.1016/S2665-9913(20)30341-6. Epub 2020 Sep 28.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

location_facility:
InflaRx Site #0303
InflaRx Site #0206
InflaRx Site #1008
InflaRx Site #0104
InflaRx Site #0301
InflaRx Site #0506
InflaRx Site #0305
InflaRx Site #1001
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InflaRx Site #1107
InflaRx Site #0202
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InflaRx Site #1011
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InflaRx Site # 0804
InflaRx Site #1005
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InflaRx Site #1009
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InflaRx Site #0208
InflaRx Site #1106

status: Completed

title: A Pragmatic Adaptive Randomized, Controlled Phase II/III Multicenter Study of IFX-1 in Patients With Severe COVID-19 Pneumonia

location_country:
Germany
Brazil
Netherlands
Mexico
Belgium
South Africa
Peru
Russian Federation
France

status_simplified: Completed


title: Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

summary: The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

status: Approved for marketing

study_type: Expanded Access

lead_sponsor: Gilead Sciences

location_country:
Germany
Ireland
Poland
Australia
Czechia
Canada
France
Slovenia
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Iceland
Romania
Belgium
Estonia
Italy
Cyprus
United Kingdom
Netherlands
Austria
Spain
Greece
Israel

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Atlantic Health System/Overlook Medical Center

location_facility: Eticka komise pro multicentircke klinicke hodnoceni Fakultni nemocnice v Motole

location_facility: NewYork-Presyterian/Columbia University Irving Medical Center- Milstein Hospital

location_facility: Atlantic Health System/ Morristown Medical Center

location_facility: IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

location_facility: University Hospital Brooklyn (SUNY Downstate)

location_facility: University of California, Medical Center (Parnassus Campus)

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Grady Health System- Grady Memorial Hospital

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Spitalul Clinic de Boli Infecţioase Sfânta Parascheva Iaşi

location_facility: New York Presbyterian Lower Manhattan Hospital

location_facility: Medical University and General Hospital Vienna

location_facility: University General Hospital of Patras Panagia I Voithia

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals

location_facility: Steward St. Elizabeth's Medical Center of Boston, Inc.

location_facility: Centro Hospitalar Universitário De São João

location_facility: NewYork-Presbyterian Brooklyn Methodist Hospital

location_facility: Texas Health Presbyterian Hospital Dallas

location_facility: Texas Department of Criminal Justice Hospital (Hospital Galveston)/University of Texas Medical Branch

location_facility: Montefiore Medical Center, Weiler Campus

location_facility: Methodist Healthcare System of San Antonio, Ltd. LLP, dha, Methodist Hospital

location_facility: Univerzitná Nemocnica L. Pasteura Košice - Pracovisko Rastislavova 43

location_facility: Wojewódzki Specjalistyczny Szpital im. dr. Wł. Biegańskiego

location_facility: AdventHealth Orlando, Investigational Drug Services

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: New York City Health and Hospitals - Coney Island

location_facility: Mercy Catholic Medical Center - Fitzgerald Campus

location_facility: Memorial Health University Medical Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University Hospital of Wales, Cardiff and Vale NHS Trust

location_facility: Robert Wood Johnson University Hospital Hamilton

location_facility: Clinical hospital for infectious disease

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Universitätsklinik für Innere Medizin II

location_facility: Banner- University Medical Center Phoenix

location_facility: Wojewódzki Szpital Specjalistyczny Megrez Sp. z o.o.

location_facility: Stony Brook University Hospital/ Stony Brook Children's

location_facility: General Hospital of Thessaloniki George Papanikolaou

location_facility: Wayne Statue University/ Detroit Receiving Hospital

location_facility: Northwestern Medicine Central DuPage Hospital

location_facility: Washington University School of Medicine

location_facility: Montefiore Health System Moses Medical Center

location_facility: Piedmont Columbus Regional-Midtown Hospital

location_facility: Sozialmedizinisches Zentrum Süd - Kaiser-Franz-Josef-Spital

location_facility: Hospital Universitario Central de Asturias

location_facility: New York City Health and New York City Health and Hospitals - Metropolitan- Metropolitan

location_facility: The Ohio State University College of Medicine

location_facility: Hackensack Meridian Health - JFK Medical Center

location_facility: St. Vincent Hospital and Health Care Center, Inc.

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: The Stamford Health Medical Group- Pulmonary Associates

location_facility: University of Maryland St. Joseph Medical Center

location_facility: Community Regional Medical Centers (CRMC)

location_facility: Our Lady of the Lakes Regional Medical Center

location_facility: New York City Health + Hospitals / Harlem

location_facility: Centro Hospitalar Universitário do Porto E.P.E.

location_facility: Brookdale University Hospital and Medical Center

location_facility: Staten Island University Hospital- Northwell Health (North Campus)

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Saint Josef Hospital Ruhr Universitaet Bochum

location_facility: Centre Hospitalier Universitaire Gabriel-Montpied

location_facility: University of Mississippi Medical Center

location_facility: Centre Hospitalier Regional Universitaire Brest Hôpital de la Cavale Blanche à Brest

location_facility: Centro Hospitalar Universitário de Lisboa Central - Hospital Curry Cabral

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: University of Washington Medical Center- Montlake Campus

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zakład Opiekuńczo Leczniczy


title: A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

acronym: ADHERE

summary: This is a Phase 2 study to evaluate the safety and efficacy of the subcutaneous formulation of efgartigimod in adults with CIDP.

ipd_sharing: Undecided

lead_sponsor: argenx

location_country:
Germany
Poland
Japan
Turkey
Czechia
Serbia
France
Hungary
Denmark
United States
Latvia
Ukraine
Romania
Belgium
China
Italy
United Kingdom
Netherlands
Austria
Spain
Taiwan
Bulgaria
Georgia
Russian Federation
Israel

location_facility:
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intervention_type: Other


acronym: Phase II Bintrafusp alfa Monotherapy in Platinum-Experienced Cervical Cancer

summary: The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.

ReferenceType: background

ReferenceCitation: Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marte JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.

version: acceptedVersion

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J, Yu H, Qin G, Sircar A, Hernandez VM, Jenkins MH, Fontana RE, Deshpande A, Locke G, Sabzevari H, Radvanyi L, Lo KM. Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-beta. Sci Transl Med. 2018 Jan 17;10(424):eaan5488. doi: 10.1126/scitranslmed.aan5488.

ReferenceCitation: Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.

oa_colors: green hybrid

evidence: open (via crossref license)

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

sponsor_collaborators: EMD Serono Research & Development Institute, Inc.

location_facility: HGB - Hospital Giovanni Battista - Mãe de Deus Center - Centro de Pesquisa Clínica - Instituto do Câncer

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Kanagawa Cancer Center - Dept of Gynecology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Regional Universitario de Malaga

location_facility: Hôpital Cochin - Hematologie et Oncologie Médicale

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Centre Oscar lambret - Service d'Oncologie medicale

location_facility: Orszagos Onkologiai Intezet - Nogyogyaszati Osztaly

location_facility: Osaka International Cancer Institute - Dept of Gynecology

location_facility: Institut Jean Godinot - Service d'hématologie et Oncologie Médicale

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz - Onkoradiologia

location_facility: Saitama Medical University International Medical Center - Dept of Gynecology/Oncology

location_facility: Cancer Institute Hospital of JFCR - Dept of Gynecology

location_facility: Kurume University Hospital - Dept of Gynecology

location_facility: NHO Kyushu Cancer Center - Dept of Gynecology

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

location_facility: Centre Hospitalier Lyon Sud - service d'oncologie medicale

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: Jikei University Hospital - Dept of Gynecology

location_facility: Stanford University Hospital and Clinics - Stanford Cancer Center

location_facility: University Hospital, University of the Ryukyus - Dept of Obstetrics/Gynecology

location_facility: Hospital Universitario Ramon y Cajal - Servicio de Oncologia

location_facility: NHO Hokkaido Cancer Center - Dept of Gynecology

location_facility: Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: National Cancer Center Hospital - Dept of Mammary Gland/Oncology

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

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

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Universitair Ziekenhuis Gent - Pneumology

location_facility: ICO Girona - Hospital Doctor Josep Trueta - Servicio de Oncologia Medica

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: Clinica Universidad de Navarra (MAD) - Oncology Service

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: AZ Groeninge - Campus Kennedylaan - account 2

title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients 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 https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

location_country:
Hungary
Argentina
Australia
Brazil
Japan
Belgium
United States
China
Korea, Republic of
Spain
Russian Federation
France


acronym: Randomized, double blind, safety, efficacy Doravirine/Islatravir in Tx naïve

lead_sponsor: Merck Sharp & Dohme LLC

summary: This is a phase 3, randomized, controlled, double-blind, multisite clinical study of a once-daily fixed dose combination (FDC) of 100 mg doravirine/0.75 mg islatravir (DOR/ISL [also known as MK-8591A]) in treatment-naïve participants with human immunodeficiency virus type-1 (HIV-1) infection. The primary objectives are to evaluate the antiretroviral activity, safety, and tolerability of DOR/ISL compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that DOR/ISL is noninferior or superior to BIC/FTC/TAF treatment based on the percentage of participants with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48.

location_facility: Hospital General Universitario Gregorio Maranon ( Site 6303)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 6401)

location_facility: Tokyo Medical University Hospital ( Site 6904)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 6006)

location_facility: Hospital Universitari Germans Trias i Pujol ( Site 6301)

location_facility: Hennepin Healthcare-Hennepin Healthcare-ID ( Site 5633)

location_facility: Floridian Clinical Research, LLC ( Site 5625)

location_facility: Toronto General Hospital - University Health Network ( Site 5705)

location_facility: Hospital Clinic i Provincial ( Site 6300)

location_facility: National Cheng Kung University Hospital ( Site 7101)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 5905)

location_facility: A.P.H. Paris, Hopital Saint Louis ( Site 6114)

location_facility: Hamilton Health Sciences- Urgent Care Centre-SIS Clinic ( Site 5703)

location_facility: Centro Cardiovascular Cardiosur ( Site 5907)

location_facility: Istituto Nazionale per Le Malattie Infettive Lazzaro Spallanzani ( Site 6405)

location_facility: Hospital Universitario 12 de Octubre ( Site 6305)

location_facility: Desmond Tutu HIV Foundation Clinical Trial Unit ( Site 6613)

location_facility: University of Alabama at Birmingham 1917 Research Clinic ( Site 5610)

location_facility: Saint Hope Foundation, Inc. ( Site 5629)

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)

location_facility: Triple O Research Institute, P.A. ( Site 5621)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 69

location_facility: Hospital Clinico de la Universidad Catolica ( Site 5903)

location_facility: Hospital Universitario San Ignacio ( Site 6005)

location_facility: McGill University Health Center - Research Institute-CVIS Clinical Research Unit ( Site 5702)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 6903)

location_facility: Azienda USL di Pescara-Presidio Ospedaliero di Pescara ( Site 6413)

location_facility: Chaim Sheba Medical Center. ( Site 6704)

location_facility: Clinica Universidad Catolica del Maule ( Site 5909)

location_facility: Family Clinical Research Unit (Fam-Cru)-Adult Infectious Diseases ( Site 6617)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)

location_facility: CHU de Bordeaux. Hopital Pellegrin ( Site 6116)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 6309)

location_facility: National Taiwan University Hospital ( Site 7100)

location_facility: Hospital Universitario La Paz ( Site 6304)

location_facility: Columbus Regional Research Institute ( Site 5616)

location_facility: Infectious Disease Specialists Of Atlanta PC ( Site 5608)

location_facility: IRCCS Policlinico San Matteo ( Site 6410)

location_facility: Ospedale San Gerardo ASST Monza ( Site 6412)

location_facility: Center Hospital of the National Center for Global Health and Medicine ( Site 6901)

location_facility: Midway Immunology and Research ( Site 5622)

location_facility: North Texas ID Consultants, PA ( Site 5604)

location_facility: Ruane Clinical Research Group, Inc. ( Site 5624)

location_facility: Texas Centers for Infectious Disease Associates P.A. ( Site 5619)

location_facility: Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 6210)

location_facility: A.O.R.N. dei Colli - Ospedale Cotugno ( Site 6407)

location_facility: Hadassah Ein Kerem Medical Center ( Site 6702)

location_facility: Universitaetsklinik Freiburg ( Site 6206)

location_facility: Hospital Universitari de Bellvitge ( Site 6312)

location_facility: EPIMED- Ges. f. epidemiolog. u. klin. Forschung in der Medizin mbH ( Site 6208)

location_facility: A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 6124)

location_facility: Centre Hospitalier de Tourcoing ( Site 6100)

location_facility: Azienda Ospedaliera San Paolo ( Site 6403)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 6404)

location_facility: Kumamoto University Hospital ( Site 6905)

location_facility: Hopital Francois Mitterrand ( Site 6119)

location_facility: Chris Hani Baragwanath Hospital - ICU ( Site 6608)

location_facility: Kaohsiung Veterans General Hospital ( Site 7102)

location_facility: Centre Hospitalier Regional du Orleans ( Site 6108)

location_facility: Wits Health Consortium. Clinical HIV Research Unit ( Site 6614)

title: A Phase 3 Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir Once-Daily in HIV-1 Infected Treatment-Naïve Participants

type: Other Identifier

type: Registry Identifier

location_country:
Germany
Italy
Colombia
Israel
Argentina
Japan
United States
Spain
South Africa
Chile
Taiwan
Canada
France


summary:
The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in:

participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
participants whose tumors express PD-L1 CPS ≥1
all participants

The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:

EFS in participants whose tumors express PD-L1 CPS ≥10
EFS in participants whose tumors express PD-L1 CPS ≥1
EFS in all participants
OS in participants whose tumors express PD-L1 CPS ≥10
OS in participants whose tumors express PD-L1 CPS ≥1
OS in all participants

ReferenceCitation: Shah MA, Bennouna J, Doi T, Shen L, Kato K, Adenis A, Mamon HJ, Moehler M, Fu X, Cho BC, Bordia S, Bhagia P, Shih CS, Desai A, Enzinger P. KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma. Future Oncol. 2021 Apr;17(10):1143-1153. doi: 10.2217/fon-2020-0969. Epub 2021 Feb 3.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

repositories_institution: Yonsei University Medical Library - YUHSpace

publisher_dissemination: Future Science Ltd

location_facility: Huai an First People s Hospital ( Site 0526)

location_facility: Instituto Medico Alexander Fleming ( Site 0063)

location_facility: Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0642)

location_facility: National Cheng Kung University Hospital ( Site 0645)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0261)

location_facility: IRCCS Policlinico San Donato ( Site 0295)

location_facility: Greater Baltimore Medical Center ( Site 0031)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0298)

location_facility: The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si

location_facility: Hangzhou First People's Hospital ( Site 0530)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0

location_facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)

location_facility: National Taiwan University Hospital ( Site 0641)

location_facility: Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0695)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0033)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)

location_facility: Clinica de Oncologia Reichow ( Site 0085)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)

location_facility: Columbus Regional Research Institute ( Site 0047)

location_facility: CHU Limoges Hopital Dupuytren ( Site 0225)

location_facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)

location_facility: National Cancer Center Hospital East ( Site 0562)

location_facility: University College Hospital NHS Foundation Trust ( Site 0701)

location_facility: Aichi Cancer Center Hospital ( Site 0563)

location_facility: MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)

location_facility: Severance Hospital Yonsei University Health System ( Site 0624)

location_facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0505)

location_facility: Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719)

location_facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718)

location_facility: National Cancer Center Hospital ( Site 0561)

location_facility: Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)

location_facility: Medical institute named after Berezin Sergey ( Site 0417)

location_facility: Sunnybrook Research Institute ( Site 0012)

location_facility: China Medical University Hospital ( Site 0646)

location_facility: Baguio General Hospital and Medical Center ( Site 0603)

location_facility: Ege Universitesi Tip Fakultesi ( Site 0457)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0411)

location_facility: Centre Georges Francois Leclerc ( Site 0223)

location_facility: Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0087)

location_facility: Pavlov First Saint Petersburg State Medical University ( Site 0426)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 0543)

location_facility: Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)

location_facility: Universitaetsklinikum Muenster ( Site 0248)

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)

location_facility: Princess Margaret Cancer Centre ( Site 0011)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 0143)

location_facility: Policlinico Universitario A. Gemelli ( Site 0297)

location_facility: Universitaetsklinikum Koeln ( Site 0251)

location_facility: Weill Cornell Medical College ( Site 0053)

location_facility: Renown Regional Medical Center ( Site 0706)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)

location_facility: Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)

location_facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)

location_facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)

location_facility: Chonnam National University Hwasun Hospital ( Site 0625)

location_facility: Orszagos Onkologiai Intezet ( Site 0263)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)

location_facility: Odense Universitetshospital ( Site 0200)

location_facility: Hospital Regional de Concepcion ( Site 0105)

location_facility: Zhongshan Hospital Fudan University ( Site 0502)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)

location_facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)

location_facility: Hammersmith Hospital-Medical Oncology ( Site 0471)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0476)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)

location_facility: Thompson Cancer Survival Center ( Site 0696)

location_facility: FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 0202)

location_facility: Princess Margaret Hospital. ( Site 0542)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)

location_facility: Royal Marsden Hospital (Sutton) ( Site 0281)

location_facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)

location_facility: The Affiliated Hospital of Xuzhou Medical University ( Site 0522)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0201)

location_facility: Charite Campus Virchow Klinikum ( Site 0250)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)

location_facility: Affiliated Hospital of Jiangsu University ( Site 0524)

location_facility: Institut De Cancerologie De Lorraine ( Site 0222)

location_facility: Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)

location_facility: Kaluga Regional Clinical Oncology Center ( Site 0424)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0237)

location_facility: Istanbul University Cerrahpasa Medical Faculty ( Site 0452)

location_facility: Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)

location_facility: Cancer Care Northwest - Spokane Valley ( Site 0036)

location_facility: MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)

location_facility: Cebu Doctors University Hospital ( Site 0604)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0477)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0235)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0106)

location_facility: Korea University Guro Hospital ( Site 0621)

location_facility: University of Kansas Cancer Center ( Site 0023)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 0538)

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0008)

location_facility: The Christie NHS Foundation Trust ( Site 0282)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)

status: Recruiting

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

enrollment_type: Anticipated

location_country:
Germany
Argentina
Japan
Brazil
Turkey
Chile
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
Romania
Belgium
China
Peru
Estonia
Philippines
Italy
Guatemala
United Kingdom
Korea, Republic of
Taiwan
Russian Federation


title: A Prospective, Randomized, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)

summary:
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.

A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.

Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.

ReferenceCitation: Capodanno D. Another Coronary Stent for Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2021 Sep 13;14(17):1884-1887. doi: 10.1016/j.jcin.2021.07.028. No abstract available.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Biotronik AG

location_country:
Germany
Italy
Poland
New Zealand
Hungary
Hong Kong
Denmark
Australia
Singapore
Netherlands
Austria
Belgium
Switzerland
Latvia
Spain
Thailand
Malaysia
France

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla

location_facility: Somogy County Kaposi Mór Teaching Hospital

location_facility: Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus

location_facility: Hospital Clinico Universitario de la Valencia

location_facility: Centre Hospitalier Universitaires Vaudoise

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio

location_facility: IRCCS Fondazione Policlinico "San Matteo"

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Assistance Publique Hopitaux de Paris (APHP)

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Städtische Kliniken Neuss, Lukaskrankenhaus GmbH

intervention_type: Device


title: A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

summary: The purpose of study is to evaluate if the addition of GSK3359609 to pembrolizumab as first-line treatment improves the efficacy of pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma/cancer (HNSCC).This is a randomized, double-blind, adaptive Phase II/III study comparing a combination of GSK3359609 inducible T cell co-stimulatory receptor (ICOS) agonist and pembrolizumab to pembrolizumab plus placebo in participants with programmed death receptor 1-ligand 1 (PD-L1) combined positive score (CPS) >=1 R/M HNSCC.

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

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Merck Sharp & Dohme LLC

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Portugal
Denmark
Switzerland
United States
Romania
China
Italy
Norway
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine the effectiveness of nivolumab adjuvant immunotherapy compared to placebo in adults and pediatric participants after complete resection of Stage IIB/C melanoma with no evidence of disease (NED) who are at high risk for recurrence.

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Istituto Nazionale Tumori Fondazione Pascale

title: A Phase 3, Randomized, Double-Blind Study of Adjuvant Immunotherapy With Nivolumab Versus Placebo After Complete Resection of Stage IIB/C Melanoma

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Denmark
Switzerland
United States
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Greece
Sweden


acronym: NAPOLI 3

summary: The purpose of this study is to look at the efficacy and safety of Irinotecan liposome injection in combination with other approved drugs used for cancer therapy, namely 5 fluorouracil/leucovorin (5FU/LV) plus oxaliplatin compared to nab-paclitaxel + gemcitabine treatment in improving the overall survival of patients not previously treated for metastatic pancreatic cancer.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

location_facility: Centro de Pesquisas Clinicas de Natal - CPCLIN

location_facility: CIP Centro Integrado de Pesquisas do Hospital de Base

location_facility: Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma

location_facility: Instituto do Cancer do Estado de São Paulo (ICESP)

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: University of Oklahoma - Health Sciences Center

location_facility: ASBL Grand Hôpital de Charleroi (GHdC), Site Notre Dame

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Siouxland Hematology - Oncology Associates, LLP

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

location_facility: David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

location_facility: University of Kentucky Markey Cancer Center

location_facility: The Center for Cancer and Blood Disorders

location_facility: Federal State Budgetary Institution - Russian Scientific Center of Radiology and Surgical Technologies n.a. academician A.M.Granov

location_facility: Torrance Memorial Physician Network Cancer Care

location_facility: Unidade Local de Saude Matosinhos E.P.E. Hospital Pedro Hispano

location_facility: Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet

location_facility: National and Kapodistrian University of Athens

location_facility: Mount Sinai Medical Center of Florida, Inc.

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

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

location_facility: SCRI-CCCIT Gemeinnutzige Gmbh- Gemeinnutzige Salzburger Landeskliniken Betriebsgesmbh

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Banner Health- MD Anderson Cancer Center

location_facility: St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare

location_facility: Alberta Health Services Cross Cancer Institute

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Chattanooga Oncology Hematology Care - Tennessee Oncology

location_facility: Presbyterian Intercommunity Hospital (PIH)

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: University Hospital Olomouc, Department of Oncology

location_facility: Cancer Research UK - Christie Hospital Foundation NHS Trust - Dept of Medical Oncology

location_facility: Hospital Regional Universitario de Malaga

location_facility: Martin Luther Universitat Halle-Wittenberg

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Centro Regional Integrado de Oncologia (CRIO)

location_facility: Compass Oncology - Rose Quarter Cancer Center

location_facility: Limited Liability Company- Clinica Druzhkovyh

location_facility: Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Dél-pesti Centrumkórház - Szent László Kórház telephely

location_facility: Instituto Brasileiro de Controle do Cancer - IBCC (Sao Paulo)

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: University of California - Irvine Medical Center

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: Florida Cancer Specialists - St. Petersburg

location_facility: University of California- Irvine Health Cancer Cente

location_facility: McGill University Faculty of Medicine - Royal Victoria Hospital

location_facility: Azienda Ospedaliero-Universitaria di Modena

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

location_facility: University of California, Los Angeles (UCLA)

location_facility: Oregon Health & Science University (OHSU)

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

location_facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

location_facility: Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital

location_facility: AUSL di Piacenza-Ospedale Guglielmo Da Saliceto

location_facility: Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

location_facility: Guy's and St. Thomas' NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Froedtert Hospital and the Medical College of Wisconsin

title: An Open-label, Randomised, Multicentre, Phase III Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Leucovorin Versus Nab-paclitaxel Plus Gemcitabine in Subjects Who Have Not Previously Received Chemotherapy for Metastatic Adenocarcinoma of the Pancreas

ipd_sharing_description: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in the published journal article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available.

location_country:
Germany
Italy
Portugal
Hungary
Israel
United Kingdom
Australia
Brazil
Austria
Belgium
United States
Korea, Republic of
Spain
Greece
Czechia
Canada
Russian Federation
France


title: A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

acronym: CERPASS

summary: To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.

lead_sponsor: Replimune Inc.

sponsor_collaborators:
Replimune Inc.
Regeneron Pharmaceuticals

location_country:
Germany
Italy
Poland
Australia
United States
Spain
Greece
Bulgaria
Canada
France

location_facility: Universitatsklinikum Tubingen Zentrum fur Dermatoonkologie

location_facility: CHU Dijon Hopital F. Mitterrand Service de Dermatologie - UMAC

location_facility: Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

location_facility: Narodowy Instytut Onkologii; Panstwowy Instytut Badawczy Oddzial w Krakowie

location_facility: "Complex Oncology Center - Plovdiv" EOOD Department of Medical Oncology and Cutaneous Cancer Diseases "

location_facility: Klinika Dermatologii, Wenerologii i Alergologii, USK im J. Mikulicza-Radeckiego we Wroclawiu

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital" OOD Department of Medical Oncology

location_facility: Istituto Tumori "Giovanni Paolo II" IRCCS

location_facility: Hospital General Universitario De Valencia

location_facility: Winship Cancer Institute of Emory University

location_facility: John Theurer Cancer Center at Hackensack Univeristy Medical Center

location_facility: University Of North Carolina at Chapel Hill

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Uniwersyteckie Centrum Kliniczne; Centrum Leczenia Czerniaka w Gdańsku

location_facility: General Hospital of Athens "Laiko", 1st Department of Medicine, University of Athens Medical School

location_facility: Universitatsklinikum Heidelberg: National Centre for Tumour Diseases (NCT)


intervention_type: Biological

summary: The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

ReferenceCitation: De Ruysscher D, Ramalingam S, Urbanic J, Gerber DE, Tan DSW, Cai J, Li A, Peters S. CheckMate 73L: A Phase 3 Study Comparing Nivolumab Plus Concurrent Chemoradiotherapy Followed by Nivolumab With or Without Ipilimumab Versus Concurrent Chemoradiotherapy Followed by Durvalumab for Previously Untreated, Locally Advanced Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 May;23(3):e264-e268. doi: 10.1016/j.cllc.2021.07.005. Epub 2021 Jul 19.

oa_host_type: publisher

location_facility: Azienda Ospedaliero-Universitaria Mater Domini

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

title: A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Switzerland
United States
Romania
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


lead_sponsor: Incyte Corporation

summary: The purpose of this study is to evaluate the safety and efficacy of pemigatinib plus pembrolizumab or pemigatinib alone versus the standard of care for participants with metastatic or unresectable urothelial carcinoma who are not eligible to receive cisplatin, are harboring FGFR3 mutation or rearrangement, and who have not received prior treatment.

location_facility: L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Spitalul Clinic Judetean de Urgenta 'Sf Apostol Andrei' Constanta

location_facility: The Center For Cancer and Blood Disorders

location_facility: Cotton-O'Neil Clinical Research Center, Hematology & Oncology

location_facility: Olsztynski Osrodek Onkologiczny Kopernik

location_facility: Fakultna Nemocnica S Poliklinikou Zilina

location_facility: Helsinki University Meilahti Tower Hospital

location_facility: Institut Claudius Regaud Oncopole Toulouse

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Christiana Care Helen F. Graham Cancer Center

location_facility: Chu de Strasbourg Hopitaux Universitaires Service D Hematologie

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Champalimaud Foundation - Champalimaud Centre For the Unknown (Champalimaud Cancer Center)

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Saitama Medical University International Medical Center

location_facility: Charleston Hematology Oncology Associates

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

location_facility: Saitama Medical Center Jichi Medical University

location_facility: Istituto Nazionale Tumori Fondazione Irccs G. Pascale

location_facility: Hopital Europeen Georges Pompidou (Hegp)

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Barts Health Nhs Trust - St Bartholomews Hospital

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Moncton Hospital - Horizon Health Network

title: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Plus Pembrolizumab Versus Pemigatinib Alone Versus Standard of Care as First-Line Treatment for Metastatic or Unresectable Urothelial Carcinoma in Cisplatin-Ineligible Participants Whose Tumors Express FGFR3 Mutation or Rearrangement (FIGHT-205)

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

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

location_country:
Finland
Germany
Ireland
Italy
Poland
Portugal
Slovakia
United Kingdom
Romania
Japan
Austria
Belgium
United States
Spain
Canada
France


title: A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis

acronym: GLOBOSTAD

summary:
Primary Objective:

To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD

Secondary Objectives:

To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching)
To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting
To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD
To collect safety data on study participants

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

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_country:
Finland
Argentina
Australia
Japan
Kuwait
Czechia
France
Colombia
Portugal
Belgium
Italy
Norway
Netherlands
Austria
Mexico
United Arab Emirates
Saudi Arabia
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Investigational site United Arab Emirates


title: A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer

acronym: LAPIS

summary: This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.

lead_sponsor: FibroGen

location_country:
Germany
Italy
Israel
United Kingdom
Austria
Belgium
United States
China
Korea, Republic of
Spain
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Technische Universität Dresden, Medizinische Klinik und Poliklinik I

location_facility: Klinikum der Universität München, Medizinische Klinik und Poliklinik III

location_facility: Institut de Cancérologie de l'Ouest Pays de Loire

location_facility: Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck

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

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School Of Medicine

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Reading Hospital McGlinn Cancer Institute

location_facility: Norton Cancer Institute, Audubon Hospital Campus

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

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

location_facility: St. Joseph's Hospital and Medical Cancer Center

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Princess Margaret Cancer Centre/University Health Network

location_facility: Chonnam National University Hwasun Hospital

location_facility: Seoul National University Budang Hospital

location_facility: Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie

location_facility: Elmhurst Memorial Hospital - Nancy W. Knowles Cancer Center

location_facility: Institut Catalá d'Oncologia (ICO Girona). Hospital Dr. Josep Trueta

location_facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center

location_facility: West China Hospital of Sichuan University

location_facility: Instituto Scientifico Romagnolog per lo Studio e la Cura dei Tumori

location_facility: Huashan Hospital affiliated with Fudan University


title: A Phase 1/2, Multi-center, Open-label Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of an Orally Available Small Molecule, CC-99282, Alone and in Combination With Anti-Lymphoma Agents in Subjects With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL).

summary: The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

design_allocation: Non-Randomized

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

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

lead_sponsor: Celgene

location_country:
Italy
Israel
Argentina
Denmark
United Kingdom
Brazil
Austria
Belgium
United States
China
Korea, Republic of
Spain
Chile
Canada
France

location_facility: Shengjing Hospital of China Medical University

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Perlmutter Cancer Center at NYU Langone Hospital-Long Island

location_facility: Oncology Institute of Hope and Innovation

location_facility: The University of Kansas - Clinical Research Center


title: TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma

acronym: TELLOMAK

summary: This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.

lead_sponsor: Innate Pharma

location_country:
Germany
Italy
Poland
Austria
Belgium
United States
Spain
France

location_facility: Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

location_facility: Centre Hospitalier Universitaire (CHU) de Liege

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Universitätsklinik für Dermatologie Medizinische Universität Graz

location_facility: Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie

location_facility: Universita di Torino, Ospedale le Molinette

location_facility: University of Pittsburgh School of Medicine

location_facility: Washington University School of Medicine

location_facility: CHRU de Montpellier - Hopital Saint Eloi

location_facility: University of California, Los Angeles (UCLA) - Medical Center

location_facility: Columbia University Department of Dermatology

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Institute of Hematology "Seràgnoli", Univeristy of Bologna

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii ul. Smoluchowskiego 17

location_facility: Consorci Hospital General Universitari de Valencia Servicio de Dermatología

location_facility: CET Centrum Medyczne Pratia Poznan ul. Poznanska 14

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Ukladu Chlonnego


summary: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

ReferenceCitation: Cardillo TM, Govindan SV, Sharkey RM, Trisal P, Arrojo R, Liu D, Rossi EA, Chang CH, Goldenberg DM. Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2/SN-38 Antibody-Drug Conjugate: Characterization and Efficacy in Pancreatic, Gastric, and Other Cancers. Bioconjug Chem. 2015 May 20;26(5):919-31. doi: 10.1021/acs.bioconjchem.5b00223. Epub 2015 May 8.

ReferenceCitation: Starodub AN, Ocean AJ, Shah MA, Guarino MJ, Picozzi VJ Jr, Vahdat LT, Thomas SS, Govindan SV, Maliakal PP, Wegener WA, Hamburger SA, Sharkey RM, Goldenberg DM. First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors. Clin Cancer Res. 2015 Sep 1;21(17):3870-8. doi: 10.1158/1078-0432.CCR-14-3321. Epub 2015 May 5.

ReferenceCitation: Goldenberg DM, Cardillo TM, Govindan SV, Rossi EA, Sharkey RM. Trop-2 is a novel target for solid cancer therapy with sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Oncotarget. 2015 Sep 8;6(26):22496-512. doi: 10.18632/oncotarget.4318. Erratum In: Oncotarget. 2020 Mar 10;11(10):942.

ReferenceCitation: Vlachostergios PJ, Jakubowski CD, Niaz MJ, Lee A, Thomas C, Hackett AL, Patel P, Rashid N, Tagawa ST. Antibody-Drug Conjugates in Bladder Cancer. Bladder Cancer. 2018 Jul 30;4(3):247-259. doi: 10.3233/BLC-180169.

ReferenceCitation: Goldenberg DM, Stein R, Sharkey RM. The emergence of trophoblast cell-surface antigen 2 (TROP-2) as a novel cancer target. Oncotarget. 2018 Jun 22;9(48):28989-29006. doi: 10.18632/oncotarget.25615. eCollection 2018 Jun 22.

ReferenceCitation: Han C, Bellone S, Schwartz PE, Govindan SV, Sharkey RM, Goldenberg DM, Santin AD. Sacituzumab Govitecan (IMMU-132) in treatment-resistant uterine serous carcinoma: A case report. Gynecol Oncol Rep. 2018 May 23;25:37-40. doi: 10.1016/j.gore.2018.05.009. eCollection 2018 Aug.

ReferenceCitation: Gray JE, Heist RS, Starodub AN, Camidge DR, Kio EA, Masters GA, Purcell WT, Guarino MJ, Misleh J, Schneider CJ, Schneider BJ, Ocean A, Johnson T, Gandhi L, Kalinsky K, Scheff R, Messersmith WA, Govindan SV, Maliakal PP, Mudenda B, Wegener WA, Sharkey RM, Goldenberg DM. Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. Clin Cancer Res. 2017 Oct 1;23(19):5711-5719. doi: 10.1158/1078-0432.CCR-17-0933. Epub 2017 Jul 5.

ReferenceCitation: Ocean AJ, Starodub AN, Bardia A, Vahdat LT, Isakoff SJ, Guarino M, Messersmith WA, Picozzi VJ, Mayer IA, Wegener WA, Maliakal P, Govindan SV, Sharkey RM, Goldenberg DM. Sacituzumab govitecan (IMMU-132), an anti-Trop-2-SN-38 antibody-drug conjugate for the treatment of diverse epithelial cancers: Safety and pharmacokinetics. Cancer. 2017 Oct 1;123(19):3843-3854. doi: 10.1002/cncr.30789. Epub 2017 May 30.

ReferenceCitation: Sahota S, Vahdat LT. Sacituzumab govitecan: an antibody-drug conjugate. Expert Opin Biol Ther. 2017 Aug;17(8):1027-1031. doi: 10.1080/14712598.2017.1331214. Epub 2017 May 22.

ReferenceCitation: Burki TK. Sacituzumab govitecan activity in advanced breast cancer. Lancet Oncol. 2017 May;18(5):e246. doi: 10.1016/S1470-2045(17)30232-2. Epub 2017 Mar 23. No abstract available.

ReferenceCitation: Bardia A, Mayer IA, Diamond JR, Moroose RL, Isakoff SJ, Starodub AN, Shah NC, O'Shaughnessy J, Kalinsky K, Guarino M, Abramson V, Juric D, Tolaney SM, Berlin J, Messersmith WA, Ocean AJ, Wegener WA, Maliakal P, Sharkey RM, Govindan SV, Goldenberg DM, Vahdat LT. Efficacy and Safety of Anti-Trop-2 Antibody Drug Conjugate Sacituzumab Govitecan (IMMU-132) in Heavily Pretreated Patients With Metastatic Triple-Negative Breast Cancer. J Clin Oncol. 2017 Jul 1;35(19):2141-2148. doi: 10.1200/JCO.2016.70.8297. Epub 2017 Mar 14.

ReferenceCitation: Cardillo TM, Sharkey RM, Rossi DL, Arrojo R, Mostafa AA, Goldenberg DM. Synthetic Lethality Exploitation by an Anti-Trop-2-SN-38 Antibody-Drug Conjugate, IMMU-132, Plus PARP Inhibitors in BRCA1/2-wild-type Triple-Negative Breast Cancer. Clin Cancer Res. 2017 Jul 1;23(13):3405-3415. doi: 10.1158/1078-0432.CCR-16-2401. Epub 2017 Jan 9.

ReferenceCitation: Chang CH, Wang Y, Zalath M, Liu D, Cardillo TM, Goldenberg DM. Combining ABCG2 Inhibitors with IMMU-132, an Anti-Trop-2 Antibody Conjugate of SN-38, Overcomes Resistance to SN-38 in Breast and Gastric Cancers. Mol Cancer Ther. 2016 Aug;15(8):1910-9. doi: 10.1158/1535-7163.MCT-16-0219. Epub 2016 May 20.

ReferenceCitation: Faltas B, Goldenberg DM, Ocean AJ, Govindan SV, Wilhelm F, Sharkey RM, Hajdenberg J, Hodes G, Nanus DM, Tagawa ST. Sacituzumab Govitecan, a Novel Antibody--Drug Conjugate, in Patients With Metastatic Platinum-Resistant Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):e75-9. doi: 10.1016/j.clgc.2015.10.002. Epub 2015 Oct 19.

ReferenceCitation: Sharkey RM, McBride WJ, Cardillo TM, Govindan SV, Wang Y, Rossi EA, Chang CH, Goldenberg DM. Enhanced Delivery of SN-38 to Human Tumor Xenografts with an Anti-Trop-2-SN-38 Antibody Conjugate (Sacituzumab Govitecan). Clin Cancer Res. 2015 Nov 15;21(22):5131-8. doi: 10.1158/1078-0432.CCR-15-0670. Epub 2015 Jun 23.

ReferenceCitation: Rugo HS, Bardia A, Marme F, Cortes J, Schmid P, Loirat D, Tredan O, Ciruelos E, Dalenc F, Pardo PG, Jhaveri KL, Delaney R, Fu O, Lin L, Verret W, Tolaney SM. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376. doi: 10.1200/JCO.22.01002. Epub 2022 Aug 26.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: McCann KE, Hurvitz SA. Innovations in targeted therapies for triple negative breast cancer. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):34-47. doi: 10.1097/GCO.0000000000000671.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O'Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldenberg DM, Sharkey RM, Maliakal P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020 Dec;31(12):1709-1718. doi: 10.1016/j.annonc.2020.09.004. Epub 2020 Sep 15.

ReferenceCitation: Rugo HS, Bardia A, Tolaney SM, Arteaga C, Cortes J, Sohn J, Marme F, Hong Q, Delaney RJ, Hafeez A, Andre F, Schmid P. TROPiCS-02: A Phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020 Apr;16(12):705-715. doi: 10.2217/fon-2020-0163. Epub 2020 Mar 30.

location_facility: Los Angeles Hematology Oncology Medical Group

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

location_facility: University of California, San Diego Moores Cancer Center

location_facility: University of California, Irvine Medical Center-Chao Family Comprehensive Cancer Center

location_facility: Hospital Quirónsalud Barcelona Instituto Oncologico Baselga

location_facility: Allina Health, Virginia Piper Cancer Institute

location_facility: DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc. DBA Blue Ridge Cancer Care

location_facility: Centrum für Hämatologie und Onkologie Bethanien

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: UCLA Department of Medicine - Hematology/Oncology

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: The West Clinic, PC dba West Cancer Center

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

location_facility: Mercy Medical Center, Medical Oncology & Hematology

location_facility: Emory University - Winship Cancer Institute

location_facility: Houston Methodist Hospital/Houston Methodist Cancer Center

location_facility: Praxisklinik für Hämatologie und Onkologie Koblenz

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: Nationales Centrum für Tumorerkrankungen - Heidelberg

location_facility: Azienda Unità Sanitaria Locale di Piacenza-Ospedale Guglielmo da Saliceto

location_facility: Laura and Isaac Perlmutter Cancer Center/NYU Langone Health

location_facility: Southern California Permanente Medical Group

location_facility: UT Health San Antonio - Mays Cancer Center

location_facility: Centre Hospitalier de L'Universite de Montreal - Hôpital Notre-Dame

location_facility: IFO Istituto Nazionale dei Tumori Regina Elena

location_facility: University of Texas Southwestern Harold C. Simmons Comprehensive Cancer Center

title: Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Least Two Prior Chemotherapy Regimens

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment

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


title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

summary: Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.

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

lead_sponsor: Amgen

location_country:
Finland
Germany
Lithuania
Slovakia
Romania
Japan
Sweden
Netherlands
Austria
United States
Spain
Greece
Turkey
Czechia
Bulgaria
Russian Federation
France

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

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

location_facility: Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

location_facility: Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

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

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Bagcilar Medipol Mega Universite Hastanesi

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Spitalul Clinic Dr Gavril Curteanu Oradea

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: US Oncology Research Investigational Products Center

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department

location_facility: Federal centre of heart, blood and endocrinology Almazova

location_facility: Rocky Mountain Cancer Centers Denver Midtown

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department

location_facility: State Budget Educational Institution of High Professional Skills Samara State Medical University

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire Archet 2

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

location_facility: United States Oncology Regulatory Affairs Corporate Office

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi


acronym: Not available at this time

lead_sponsor: Acerta Pharma BV

summary: The purpose of this study is to evaluate the efficacy and safety of acalabrutinib in combination with venetoclax and acalabrutinib in combination with venetoclax with and without obinutuzumab compared to chemoimmunotherapy in subjects with previously untreated CLL

ReferenceCitation: Davids MS, Lampson BL, Tyekucheva S, Wang Z, Lowney JC, Pazienza S, Montegaard J, Patterson V, Weinstock M, Crombie JL, Ng SY, Kim AI, Jacobson CA, LaCasce AS, Armand P, Arnason JE, Fisher DC, Brown JR. Acalabrutinib, venetoclax, and obinutuzumab as frontline treatment for chronic lymphocytic leukaemia: a single-arm, open-label, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1391-1402. doi: 10.1016/S1470-2045(21)00455-1. Epub 2021 Sep 14.

ReferenceCitation: Gordon MJ, Danilov AV. The evolving role of Bruton's tyrosine kinase inhibitors in chronic lymphocytic leukemia. Ther Adv Hematol. 2021 Jan 30;12:2040620721989588. doi: 10.1177/2040620721989588. eCollection 2021.

publisher_dissemination: SAGE Publications

sponsor_collaborators:
Acerta Pharma BV
AstraZeneca

title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination With Venetoclax With and Without Obinutuzumab Compared to Investigator's Choice of Chemoimmunotherapy in Subjects With Previously Untreated Chronic Lymphocytic Leukemia Without Del(17p) or TP53 Mutation

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Slovakia
Hungary
Denmark
United States
Ukraine
China
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel