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.

lead_sponsor: Galectin Therapeutics Inc.

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

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Pioneer Research Solutions Inc - Houston - Stancliff Rd

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

location_facility: Gastroenterology Associates of Fredericksburg

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

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Gastroenterology Associates of Western Michigan

location_facility: Centre Hospitalier Universitaire d'Amiens

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

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

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

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

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

location_facility: Penn State Milton S. Hershey Medical Center

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

location_facility: University of Cincinnati Physicians Company, LLC

location_facility: Medical University of South Carolina (MUSC)

location_facility: Bon Secours Liver Institute of Virginia - Newport News

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

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

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

location_facility: Digestive Research Alliance of Michiana, LLC

location_facility: University of Virginia School of Medicine

location_facility: NewYork-Presbyterian Hospital/Weill Cornell Medical Center

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

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

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Complexo Hospitalario Universitario de Pontevedra

location_facility: University Hospitals Cleveland Medical Center

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

location_facility: Yonsei University, Wonju Severance Christian Hospital

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

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: The Ohio State University Wexner Medical Center

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

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: University Diabetes & Endocrine Consultants

location_facility: Clinique Universitaire De Bruxelles Hôpital Erasme VZW

location_facility: Groupe sante CHC - Clinique du MontLegia

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: The Jefferson Digestive Health Institute - Thomas Jefferson University

location_facility: Bon Secours Liver Institute of Virginia - Richmond

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

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: Hospital Universitario Marqués de Valdecilla


status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Drug

title: A Phase 2, Multicenter, Open-label, Multi-cohort Study to Assess Safety and Efficacy of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers

study_completion_date_type: Anticipated

lead_sponsor: Celgene

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Non-Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Actual

location_country:
Poland
Spain
Italy
United Kingdom
United States
France

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Augusta University - Georgia Cancer Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Novant Health Presbyterian Medical Center

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Insular-Maternal and Child University Hospital Complex

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

summary:
This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies.

The primary objectives of the study are to evaluate the overall response rate of subjects treated with CC-90011 in combination with nivolumab in three cohorts:

Cohort A: SCLC in ICI naïve subjects
Cohort B: SCLC in ICI progressor subjects
Cohort C: sqNSCLC in ICI progressor subjects Overall response rate is defined as the proportion of subjects in the treated population who had complete response (CR) or partial response (PR) as assessed by Investigator review per RECIST v1.1.

In Cohort A, expected ORR for nivolumab monotherapy is 14% while target ORR is 30%. To achieve at least 80% power with one-sided type 1 error 0.1, 39 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 12 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 2 or more subjects responding, Cohort A will continue to enroll an additional 27 subjects. If 1 or less subjects respond in stage 1, Cohort A will stop for futility.

In Cohort B and C, expected ORR for nivolumab monotherapy is 5% while target ORR is 15%. To achieve at least 80% power with one-sided type 1 error 0.1, 48 subjects will be enrolled according to a 2-stage group sequential design based on a binomial test. In stage 1, 14 subjects will be enrolled and treated with CC-90011 in combination with nivolumab. If there are 1 or more subjects responding, Cohort B and C will continue to enroll an additional 34 subjects each. If 0 subjects respond in stage 1, Cohort B and C will stop for futility.

lead_sponsor_type: industriel

status_simplified: Ongoing


ipd_sharing: No

status: Completed

acronym: PANAMO

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

study_completion_date_type: Actual

lead_sponsor: InflaRx GmbH

design_allocation: Randomized

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, Rückinger 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 Sep 7. pii: S2213-2600(22)00297-1. doi: 10.1016/S2213-2600(22)00297-1. [Epub ahead of print]

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.

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:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

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.

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

location_facility:
University Nantes
University Greifswald
University Ryazan
Inflarx Site
Inflarx site
University Suresnes
University Nuevo Leon Monterrey
University Nice
University Simon Campos
University St. Etienne
University Culiacan
University Aachen
University Paris 1
University Paris 2
University Eindhoven
University of Chiuhuahua
University Porto Alegre
University of Peru
University Moscow
University Leuven
University Paris 3
University Dresden
Hospital Grenoble
University of Somerset West
University Augsburg
University Brussels
University Lima II
Inflarx
University Berlin- Charite

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)

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

location_facility: Washington University School of Medicine

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

location_facility: Universitätsklinik für Innere Medizin II

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

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

location_facility: Centre Hospitalier Universitaire Saint Pierre

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Memorial Health University Medical Center

location_facility: Saint Josef Hospital Ruhr Universitaet Bochum

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

location_facility: Clinical hospital for infectious disease

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Our Lady of the Lakes Regional Medical Center

location_facility: Montefiore Medical Center, Weiler Campus

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

location_facility: Grady Health System- Grady Memorial Hospital

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

location_facility: IRCCS Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho

location_facility: University Hospital Brooklyn (SUNY Downstate)

location_facility: Wielospecjalistyczny Szpital Miejski Im Józefa Strusia Zakład Opiekuńczo Leczniczy

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

location_facility: AdventHealth Orlando, Investigational Drug Services

location_facility: Piedmont Columbus Regional-Midtown Hospital

location_facility: Northwestern Medicine Central DuPage Hospital

location_facility: Hospital General Universitario Gregorio Maranon

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

location_facility: University General Hospital of Patras Panagia I Voithia

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

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

location_facility: The Ohio State University College of Medicine

location_facility: University of Maryland St. Joseph Medical Center

location_facility: Centro Hospitalar Universitário De São João

location_facility: Wayne Statue University/ Detroit Receiving Hospital

location_facility: Mercy Catholic Medical Center - Fitzgerald Campus

location_facility: Medical University and General Hospital Vienna

location_facility: Atlantic Health System/Overlook Medical Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: The Stamford Health Medical Group- Pulmonary Associates

location_facility: Robert Wood Johnson University Hospital Hamilton

location_facility: Montefiore Health System Moses Medical Center

location_facility: University of Mississippi Medical Center

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

location_facility: Texas Health Presbyterian Hospital Dallas

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

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

location_facility: Centre Hospitalier Universitaire Gabriel-Montpied

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Hospital Clinico Universitario de Valladolid

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

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

location_facility: New York City Health and Hospitals - Coney Island

location_facility: NewYork-Presbyterian Brooklyn Methodist Hospital

location_facility: Community Regional Medical Centers (CRMC)

location_facility: New York Presbyterian Lower Manhattan Hospital

location_facility: Azienda Ospedaliero - Universitaria Careggi

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

location_facility: University of Washington Medical Center- Montlake Campus

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

location_facility: Hackensack Meridian Health - JFK Medical Center

location_facility: Banner- University Medical Center Phoenix

location_facility: Spitalul Clinic de Boli Infecţioase Sfânta Parascheva Iaşi

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

location_facility: Atlantic Health System/ Morristown Medical Center

location_facility: Brookdale University Hospital and Medical Center

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: New York City Health + Hospitals / Harlem

location_facility: Hospital Universitario Central de Asturias

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

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

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

location_facility: General Hospital of Thessaloniki George Papanikolaou

status_simplified: Unknown


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.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: argenx

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

location_facility:
Investigator site 112
Investigator site 102
Investigator site 150
Investigator site 42
Investigator site 78
Investigator site 173
Investigator site 39
Investigator site 183
Investigator site 116
Investigator site 137
Investigator site 63
Investigator site 47
Investigator site 24
Investigator site 65
Investigator Site 7
Investigator site 86
Investigator site 2
Investigator site 140
Investigator site 13
Investigator site 9
Investigator site 76
Investigator site 85
Investigator site 55
Investigator site 138
Investigator site 158
Investigator site 56
Investigator site 92
Investigator site 179
Investigator site 75
Investigator site 186
Investigator site 160
Investigator site 123
Investigator site 142
Investigator site 96
Investigator site 124
Investigator site 80
Investigator site 136
Investigator site 68
Investigator site 69
Investigator site 148
Investigator site 20
Investigator site 159
Investigator site 12
Investigator site 51
Investigation site 121
Investigator site 113
Investigator site 146
Investigator site 16
Investigator site 98
Investigator Site 4
Investigator site 134
Investigator site 104
Investigator site 32
Investigator site 162
Investigator site 151
Investigator site 153
Investigator site 189
Investigator site 34
Investigator site 99
Investigator site 107
Investigator site 46
Investigator site 191
Investigator site 70
Investigator site 171
Investigator site 167
Investigator site 79
Investigator site 10
Investigator site 105
Investigator site 119
Investigator site 175
Investigator site 88
Investigator site 43
Investigator site 30
Investigator site 33
Investigator site 163
Investigator site 122
Investigator site 117
Investigator site 52
Investigator site 59
Investigator site 91
Investigator site 178
Investigator site 35
Investigator site 72
Investigator site 135
Investigator site 25
Investigator site 154-155
Investigator site 177
Investigator site 94
Investigator Site 5
Investigator site 132
Investigator site 27
Investigator site 23
Investigator site 184
Investigator site 120
Investigator site 95
Investigator site 82
Investigator site 118
Investigator site 26
Investigator site 54
Investigator site 67
Investigator site 90
Investigator site 129
Investigator site 50
Investigator site 156
Investigator site 141
Investigator site 73
Investigator site 15
Investigator site 87
Investigator site 11
Investigator site 133
Investigator site 143-145
Investigator site 44
Investigator site 109
Investigator site 22
Investigator site 31
Investigator site 188
Investigator site 157
Investigator site 185
Investigator site 115
Investigator site 60
Investigator site 66
Investigator site 40
Investigator site 37
Investigator site 45
Investigator site 168
Investigator site 187
Investigator site 111
Investigator site 103
Investigator site 74
Investigator site 152
Investigator site 28
Investigator site 93
Investigator site 180
Investigator site 62
Investigator site 110
Investigator site 174
Investigator site 114
Investigator site 100
Investigator site 108
Investigator site 101
Investigator site 139
Investigator site 126
Investigator site 41
Investigator site 176
Investigator Site 3
Investigator site 84
Investigator site 81
Investigator Site 6
Investigator site 38
Investigator site 61
Investigator site 83
Investigator site 161
Investigator site 58
Investigator site 77
Investigator site 71
Investigator site 166
Investigator site 14
Investigator site 169
Investigator site 89
Investigator site 147
Investigator site 125
Investigator site 182
Investigator site 53
Investigator site 97
Investigator site 19
Investigator site 149
Investigator site 170
Investigator site 165
Investigator site 131
Investigator site 17
Investigator site 190
Investigator site 127
Investigator site 21
Investigator site 18
Investigator site 8
Investigator site 49
Investigator site 164
Investigator site 29
Investigator site 1
Investigator site 130
Investigator site 106
Investigator site 64
Investigator site 181
Investigator site 128
Investigator site 48
Investigator site 172
Investigator site 57

intervention_type: Biological


ipd_sharing: Yes

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

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

lead_sponsor: EMD Serono Research & Development Institute, Inc.

ReferenceType: background

ReferenceCitation: Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marté 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 TGFβ, 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.

ReferenceCitation: Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J, Yu H, Qin G, Sircar A, Hernández 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-β. Sci Transl Med. 2018 Jan 17;10(424). pii: 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-β and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.

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

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Hospital Regional Universitario de Malaga

location_facility: Universitair Ziekenhuis Gent - Pneumology

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

location_facility: Jikei University Hospital - Dept of Gynecology

location_facility: Centre Oscar lambret - Service d'Oncologie medicale

location_facility: Shanghai Cancer Hospital, Fudan University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Osaka International Cancer Institute - Dept of Gynecology

location_facility: NHO Hokkaido Cancer Center - Dept of Gynecology

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

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

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

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

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Orszagos Onkologiai Intezet - Nogyogyaszati Osztaly

location_facility: Hospital Universitario 12 de Octubre - Servicio de Oncologia

location_facility: Kurume University Hospital - Dept of Gynecology

location_facility: Hospital Universitario Ramon y Cajal - Servicio de Oncologia

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

location_facility: AZ Groeninge - Campus Kennedylaan - account 2

location_facility: Stanford University Hospital and Clinics - Stanford Cancer Center

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Hôpital Cochin - Hematologie et Oncologie Médicale

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz - Onkoradiologia

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

location_facility: Cancer Institute Hospital of JFCR - Dept of Gynecology

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

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

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

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

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

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

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

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

location_facility: Kanagawa Cancer Center - Dept of Gynecology

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: NHO Kyushu Cancer Center - Dept of Gynecology

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

summary: The main purpose of this study is 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.


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

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

lead_sponsor: Merck Sharp & Dohme LLC

type: Registry Identifier

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

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

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

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

location_facility: Hospital Universitari de Bellvitge ( Site 6312)

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

location_facility: Hopital Francois Mitterrand ( Site 6119)

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

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

location_facility: Universitaetsklinik Freiburg ( Site 6206)

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

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

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

location_facility: Hospital Universitario 12 de Octubre ( Site 6305)

location_facility: Midway Immunology and Research ( Site 5622)

location_facility: National Taiwan University Hospital ( Site 7100)

location_facility: Kaohsiung Veterans General Hospital ( Site 7102)

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

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

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

location_facility: ASST Fatebenefratelli-Ospedale Sacco ( Site 6400)

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

location_facility: IRCCS Policlinico San Matteo ( Site 6410)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 6303)

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

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

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

location_facility: Centre Hospitalier Regional du Orleans ( Site 6108)

location_facility: Kumamoto University Hospital ( Site 6905)

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

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

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 6307)

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

location_facility: Centro Cardiovascular Cardiosur ( Site 5907)

location_facility: Hospital Clinic i Provincial ( Site 6300)

location_facility: Floridian Clinical Research, LLC ( Site 5625)

location_facility: Chaim Sheba Medical Center. ( Site 6704)

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

location_facility: Tokyo Medical University Hospital ( Site 6904)

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

location_facility: Azienda Ospedaliera San Paolo ( Site 6403)

location_facility: Hadassah Ein Kerem Medical Center ( Site 6702)

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

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

location_facility: National Cheng Kung University Hospital ( Site 7101)

location_facility: Hospital Universitario San Ignacio ( Site 6005)

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

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

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

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

location_facility: Columbus Regional Research Institute ( Site 5616)

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

location_facility: Hospital Universitario La Paz ( Site 6304)

location_facility: Ospedale San Gerardo ASST Monza ( Site 6412)

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

location_facility: Clinica Universidad Catolica del Maule ( Site 5909)

location_facility: Centre Hospitalier de Tourcoing ( Site 6100)

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

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

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

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

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.


acronym: LIBERTY-BP

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

lead_sponsor: Regeneron Pharmaceuticals

ipd_sharing_description: All individual patient data (IPD) that underlie publicly available results will be considered for sharing

location_country:
Poland
Australia
United States
France
Japan
Germany

location_facility:
Regeneron Study Site
Regeneron Study Site 2
Regeneron Study site
Regeneron Study site'
Regeneron Study Site 1

summary:
The primary objective of the study is to demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP).

The secondary objectives of the study are:

To evaluate the OCS-sparing effects of dupilumab in patients with BP
To evaluate the effect of dupilumab on itch in patients with BP
To evaluate the effects of dupilumab on health-related quality of life measures in patients with BP
To evaluate the effect of dupilumab in circulating BP180 and BP230 autoantibody titers
To assess the safety and tolerability of dupilumab administered to patients with BP
To characterize the trough concentrations of functional dupilumab over time following administration of dupilumab in patients with BP
To assess the immunogenicity of dupilumab in patients with BP over time


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

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


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

lead_sponsor: Bristol-Myers Squibb

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

location_facility: Nova Scotia Health Authority (Capital District Health Authority)

location_facility: Prof Dr I Chiricuta Institute of Oncology

location_facility: Nationales Centrum Fur Tumorerkrankungen (Nct)

location_facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

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.


acronym: NAPOLI 3

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

lead_sponsor: Ipsen

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

location_facility: University of California, Los Angeles (UCLA)

location_facility: The Center for Cancer and Blood Disorders

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

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

location_facility: Limited Liability Company- Clinica Druzhkovyh

location_facility: Centro de Pesquisas Clinicas de Natal - CPCLIN

location_facility: University of California- Irvine Health Cancer Cente

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

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

location_facility: McGill University Faculty of Medicine - Royal Victoria Hospital

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

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Oregon Health & Science University (OHSU)

location_facility: Mount Sinai Medical Center of Florida, Inc.

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Alberta Health Services Cross Cancer Institute

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Queen Elizabeth II Health Sciences Centre

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

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

location_facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

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

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

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: Hospital de la Santa Creu i Sant Pau Barcelona

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

location_facility: Presbyterian Intercommunity Hospital (PIH)

location_facility: AUSL di Piacenza-Ospedale Guglielmo Da Saliceto

location_facility: University of Oklahoma - Health Sciences Center

location_facility: Krankenhaus St. Franziskus - Kliniken Maria Hilf GmbH

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

location_facility: Mercy Health - St. Elizabeth Youngstown Hospital

location_facility: Martin Luther Universitat Halle-Wittenberg

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: University Hospital Olomouc, Department of Oncology

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

location_facility: Banner Health- MD Anderson Cancer Center

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

location_facility: Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

location_facility: Compass Oncology - Rose Quarter Cancer Center

location_facility: Siouxland Hematology - Oncology Associates, LLP

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

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

location_facility: Chattanooga Oncology Hematology Care - Tennessee Oncology

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

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

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

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Cancer and Hematology Centers of Western Michigan

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

location_facility: Florida Cancer Specialists - St. Petersburg

location_facility: Hospital Regional Universitario de Malaga

location_facility: Washington University School of Medicine in St. Louis

location_facility: University of Kentucky Markey Cancer Center

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

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Torrance Memorial Physician Network Cancer Care

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

location_facility: Centre Hospitalier Universitaire de Poitiers - Poitiers University Hospital

location_facility: CIP Centro Integrado de Pesquisas do Hospital de Base

location_facility: National and Kapodistrian University of Athens

location_facility: Centro Regional Integrado de Oncologia (CRIO)

location_facility: University of California - Irvine Medical Center

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: Dél-pesti Centrumkórház - Szent László Kórház telephely

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.


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)

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.

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

location_facility:
Local Institution - 0068
Local Institution - 0078
Local Institution - 0148
Local Institution - 0036
Local Institution - 0197
Local Institution - 0138
Local Institution - 0127
Local Institution - 0218
Local Institution - 0033
Local Institution - 0179
Local Institution - 0003
Local Institution - 0211
CHI St. Joseph Cancer Center
Local Institution - 0042
Local Institution - 0038
Local Institution - 0237
Local Institution - 0076
Local Institution - 0075
Local Institution - 0196
Local Institution - 0026
Local Institution - 0213
Local Institution - 0073
Local Institution - 0108
Local Institution - 0100
Local Institution - 0001
Local Institution - 0180
Local Institution - 0203
Local Institution - 0052
Local Institution - 0081
Local Institution - 0019
Local Institution - 0149
Local Institution - 0227
Local Institution - 0097
Local Institution - 0050
Local Institution - 0164
Local Institution - 0043
Local Institution - 0124
Local Institution - 0178
Local Institution - 0077
Local Institution - 0070
Local Institution - 0189
Local Institution - 0195
Local Institution - 0006
Local Institution - 0206
Local Institution - 0147
Local Institution - 0192
Local Institution - 0107
Local Institution - 0106
Local Institution - 0175
Local Institution - 0119
Local Institution - 0139
Local Institution - 0040
Local Institution - 0162
Local Institution - 0165
Local Institution - 0062
Local Institution - 0010
Local Institution - 0112
Local Institution - 0131
Local Institution - 0170
Local Institution - 0071
Local Institution - 0102
Local Institution - 0224
Local Institution - 0183
Local Institution - 0188
Local Institution - 0034
Local Institution - 0199
Local Institution - 0023
Local Institution - 0214
Local Institution - 0210
Local Institution - 0161
Local Institution - 0115
Local Institution - 0060
Local Institution - 0168
Local Institution - 0109
Local Institution - 0039
Local Institution - 0035
Local Institution - 0064
Local Institution
Local Institution - 0234
Local Institution - 0045
Local Institution - 0002
Local Institution - 0058
Local Institution - 0004
Local Institution - 0204
Local Institution - 0089
Local Institution - 0116
Local Institution - 0104
Local Institution - 0233
Local Institution - 0047
Local Institution - 0135
Local Institution - 0166
Local Institution - 0057
Local Institution - 0061
Local Institution - 0207
Local Institution - 0186
Local Institution - 0051
Local Institution - 0015
Local Institution - 0208
Local Institution - 0025
Local Institution - 0030
Local Institution - 0171
Local Institution - 0209
Local Institution - 0082
Local Institution - 0114
Local Institution - 0087
Local Institution - 0101
Local Institution - 0123
Local Institution - 0198
Local Institution - 0028
Local Institution - 0054
Local Institution - 0235
Local Institution - 0041
Local Institution - 0065
Local Institution - 0129
Local Institution - 0099
Local Institution - 0133
Local Institution - 0083
Local Institution - 0007
Local Institution - 0063
Local Institution - 0174
Local Institution - 0095
Local Institution - 0126
Local Institution - 0072
Local Institution - 0200
Local Institution - 0067
Local Institution - 0212
Local Institution - 0130
Local Institution - 0232
Local Institution - 0152
Local Institution - 0017
Local Institution - 0049
Local Institution - 0037
Local Institution - 0056
Local Institution - 0012
Local Institution - 0027
Local Institution - 0217
Local Institution - 0205
Local Institution - 0096
Local Institution - 0059
Local Institution - 0201
Local Institution - 0090
Local Institution - 0048
Local Institution - 0125
Local Institution - 0005
Local Institution - 0021
Local Institution - 0105
Local Institution - 0154
Local Institution - 0219
Local Institution - 0080
Local Institution - 0018
Local Institution - 0098
Local Institution - 0143
Local Institution - 0024
Local Institution - 0092
Local Institution - 0140
Local Institution - 0053
Local Institution - 0167
Local Institution - 0202
Local Institution - 0191
Local Institution - 0134
Local Institution - 0120
Local Institution - 0020
Local Institution - 0136
Local Institution - 0031
Local Institution - 0150
Local Institution - 0222
Local Institution - 0146
Local Institution - 0086
Local Institution - 0091
Local Institution - 0216
Local Institution - 0184
GCM Medical Group
Local Institution - 0014
Local Institution - 0044
Local Institution - 0009
Local Institution - 0145
Local Institution - 0084

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).


status: Terminated

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)

lead_sponsor: Incyte Corporation

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

location_facility: Moncton Hospital - Horizon Health Network

location_facility: Christiana Care Helen F. Graham Cancer Center

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

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

location_facility: Charleston Hematology Oncology Associates

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

location_facility: The Center For Cancer and Blood Disorders

location_facility: Barts Health Nhs Trust - St Bartholomews Hospital

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

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Helsinki University Meilahti Tower Hospital

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Saitama Medical Center Jichi Medical University

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Saitama Medical University International Medical Center

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Chu de Strasbourg Hopitaux Universitaires Service D Hematologie

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Hospital Clinico Universitario de Valencia

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

location_facility: Hopital Europeen Georges Pompidou (Hegp)

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Istituto Nazionale Tumori Fondazione Irccs G. Pascale

location_facility: Olsztynski Osrodek Onkologiczny Kopernik

location_facility: Fakultna Nemocnica S Poliklinikou Zilina

location_facility: Institut Claudius Regaud Oncopole Toulouse

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.


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

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

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

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

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Huashan Hospital affiliated with Fudan University

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

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

location_facility: Norton Cancer Institute, Audubon Hospital Campus

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

location_facility: Indiana University Melvin and Bren Simon Comprehensive Cancer Center

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

location_facility: Reading Hospital McGlinn Cancer Institute

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

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Grande Ospedale Metropolitano Niguarda, Oncologia Medica Falck

location_facility: Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Hospital General Universitario Gregorio Marañon

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

location_facility: West China Hospital of Sichuan University

location_facility: Technische Universität Dresden, Medizinische Klinik und Poliklinik I

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

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

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

location_facility: Seoul National University Budang Hospital

location_facility: Princess Margaret Cancer Centre/University Health Network

location_facility: University College London Hospitals NHS Foundation Trust


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:
Poland
Spain
Italy
Austria
United States
France
Belgium
Germany

location_facility: Universitätsklinik für Dermatologie Medizinische Universität Graz

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Washington University School of Medicine

location_facility: Columbia University Pediatric Neuromuscular Center Columbia UMC

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

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

location_facility: CHRU de Montpellier - Hopital Saint Eloi

location_facility: Universita di Torino, Ospedale le Molinette

location_facility: Consorci Hospital General Universitari de Valencia Servicio de Dermatología

location_facility: Hospital Clinico Universitario de Salamanca

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

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: CET Centrum Medyczne Pratia Poznan ul. Poznanska 14

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: University of Pittsburgh School of Medicine

location_facility: Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie

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

location_facility: Centre Hospitalier Universitaire (CHU) de Liege


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

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. 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. Review.

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. Review.

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. Review.

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.

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, Marmé F, Cortes J, Schmid P, Loirat D, Trédan 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.

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. Review.

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, Marmé F, Hong Q, Delaney RJ, Hafeez A, André 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_country:
Spain
Italy
United Kingdom
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Houston Methodist Hospital/Houston Methodist Cancer Center

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Hospital Clinico Universitario de Santiago de Compostela

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

location_facility: Emory University - Winship Cancer Institute

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Southern California Permanente Medical Group

location_facility: UCLA Department of Medicine - Hematology/Oncology

location_facility: Allina Health, Virginia Piper Cancer Institute

location_facility: Mercy Medical Center, Medical Oncology & Hematology

location_facility: IFO Istituto Nazionale dei Tumori Regina Elena

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: University of Miami - Sylvester Comprehensive Cancer Center

location_facility: Nationales Centrum für Tumorerkrankungen - Heidelberg

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Los Angeles Hematology Oncology Medical Group

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

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

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: UT Health San Antonio - Mays Cancer Center

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

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Fleurimont

location_facility: Hospital Quirónsalud Barcelona Instituto Oncologico Baselga

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Praxisklinik für Hämatologie und Onkologie Koblenz

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

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Centrum für Hämatologie und Onkologie Bethanien

location_facility: University of California, San Diego Moores Cancer Center

location_facility: DIAKOVERE Krankenhaus gGmbH Henriettenstift - Standort Kirchrode

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: The West Clinic, PC dba West Cancer Center

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

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

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).


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

location_facility: Bagcilar Medipol Mega Universite Hastanesi

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: United States Oncology Regulatory Affairs Corporate Office

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

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centre Hospitalier Universitaire Archet 2

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

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin

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

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: Spitalul Universitar de Urgenta Bucuresti

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

location_facility: Rocky Mountain Cancer Centers Denver Midtown

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

location_facility: Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden

location_facility: Spitalul Clinic Dr Gavril Curteanu Oradea

location_facility: Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

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

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

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

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Federal centre of heart, blood and endocrinology Almazova

location_facility: US Oncology Research Investigational Products Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

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

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta

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


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

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. Review.

lead_sponsor: Acerta Pharma BV

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


title: GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 Weeks

lead_sponsor: Galecto Biotech AB

ReferenceCitation: Rebelo AL, Chevalier MT, Russo L, Pandit A. Role and therapeutic implications of protein glycosylation in neuroinflammation. Trends Mol Med. 2022 Apr;28(4):270-289. doi: 10.1016/j.molmed.2022.01.004. Epub 2022 Feb 1. Review.

ReferenceCitation: Park AM, Khadka S, Sato F, Omura S, Fujita M, Hsu DK, Liu FT, Tsunoda I. Galectin-3 as a Therapeutic Target for NSAID-Induced Intestinal Ulcers. Front Immunol. 2020 Sep 23;11:550366. doi: 10.3389/fimmu.2020.550366. eCollection 2020.

location_country:
Poland
Spain
Ireland
Georgia
Australia
Italy
Canada
United Kingdom
Ukraine
United States
France
Israel
Belgium
Germany

location_facility: CHU de la Réunion Site SUD (Terre Sainte)

location_facility: Advanced Research for Health Improvement

location_facility: ZMS Zentrum für medizinische Studien GmbH

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University of Utah Health Scieces Center

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)

location_facility: Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Jasper Summit Research, LLC Pulmonary & Sleep Associates

location_facility: Dr Anees Medicine Professional Corporation

location_facility: National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky

location_facility: Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio

location_facility: Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau

location_facility: Harvard Medical School - Brigham and Womens Hospital (BWH)

location_facility: LaPorte County Institute for Clinical Research

location_facility: National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR

location_facility: Firestone Institute for Respiratory Health

location_facility: Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P

location_facility: University of Texas Health Sciences Center at Houston

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

location_facility: Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil

location_facility: Klifeck GmbH Praxis Med. Gerald Eckhardt

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: University-Hospital Policlinico Vittorio Emanuele

location_facility: Lungenfachklinik Immenhausen Department for Clinical Studies

location_facility: Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne

location_facility: Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc

location_facility: University Hospital of Mondena-AOU - Policlinico di Modena

location_facility: Aintree Unversity Hospital NHS Foundation Trust

location_facility: Pulmonary Institute Rabin Medical Center

location_facility: Institute for Respiratory Health Sir Charles Gairdner Hospital

location_facility: Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie

location_facility: University of Texas Health Centre at Houston

location_facility: AOU Città della Salute e della Scienza, PO Molinette

location_facility: Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital

location_facility: Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen

location_facility: Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou

location_facility: Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu

location_facility: Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera Universitaria Senese

summary: This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.


title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) in Participants With Treatment-naïve, Metastatic Nonsmall Cell Lung Cancer (NSCLC) Whose Tumors Have a Tumor Proportion Score (TPS) Greater Than or Equal to 1% (LEAP-007)

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) in treatment-naïve adults with no prior systemic therapy for their metastatic non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

The primary study hypotheses are that: 1) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); and 2) the combination of pembrolizumab and lenvatinib is superior to pembrolizumab alone as assessed by Overall Survival (OS).

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

location_country:
Poland
Taiwan
Italy
Russian Federation
Australia
Estonia
Canada
Mexico
Ukraine
Hungary
Korea, Republic of
United States
France
China
Israel
Colombia
Japan
Malaysia
Turkey

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 0262)

location_facility: Sakarya Universitesi Egitim ve Arastirma Hastanesi ( Site 0323)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0366)

location_facility: SMG-SNU Boramae Medical Center ( Site 0078)

location_facility: CHU de Grenoble - Hopital Michallon ( Site 0169)

location_facility: Consultorios de Medicina Especializada del Sector Privado ( Site 0388)

location_facility: Centre hospitalier Toulon Sainte-Musse ( Site 0172)

location_facility: Taipei Veterans General Hospital ( Site 0089)

location_facility: Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi ( Site 0314)

location_facility: Peking Union Medical College Hospital ( Site 0105)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0269)

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0243)

location_facility: 1st Affil Hosp of Med College of Xi'an Jiaotong University ( Site 0103)

location_facility: Cone Health Cancer Center at Alamance Regional ( Site 0527)

location_facility: Nippon Medical School Hospital ( Site 0024)

location_facility: The Prince Charles Hospital ( Site 0011)

location_facility: Centro di Riferimento Oncologico CRO ( Site 0235)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0203)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0250)

location_facility: MI Odessa Regional Oncological Centre ( Site 0333)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0265)

location_facility: Okayama University Hospital ( Site 0020)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 0319)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0063)

location_facility: Park Nicollet Frauenshuh Cancer Center ( Site 0554)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0162)

location_facility: 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0114)

location_facility: SA Tartu Ulikooli Kliinikum ( Site 0160)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0252)

location_facility: The First Affiliated Hospital Zhejiang University ( Site 0106)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0518)

location_facility: Kyiv City Clinical Oncology Centre ( Site 0339)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 0346)

location_facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0234)

location_facility: Policlinico Gemelli di Roma ( Site 0237)

location_facility: University Malaya Medical Centre ( Site 0061)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0374)

location_facility: St John of God Murdoch Medical Clinic ( Site 0001)

location_facility: Regional Centre of Oncology-Thoracic organs ( Site 0337)

location_facility: University of Missouri Health Care ( Site 0555)

location_facility: Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 0233)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0015)

location_facility: Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 0318)

location_facility: West China Hospital of Sichuan University ( Site 0117)

location_facility: Oregon Health Sciences University ( Site 0544)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0185)

location_facility: City Clinical Oncology Center ( Site 0260)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 0322)

location_facility: Hangzhou First People's Hospital ( Site 0109)

location_facility: Chungbuk National University Hospital ( Site 0079)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0213)

location_facility: National Cheng Kung University Hospital ( Site 0086)

location_facility: Szpital Uniwersytecki im. Karola Marcinkowskiego ( Site 0247)

location_facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 0324)

location_facility: Instituto Nacional de Cancerologia. ( Site 0382)

location_facility: Anne Arundel Medical Center Oncology and Hematology ( Site 0514)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0181)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0091)

location_facility: Alaska Clinical Research Center ( Site 0511)

location_facility: SPZOZ USK nr 1 im. Norberta Barlickiego UM w Lodzi ( Site 0256)

location_facility: Ironwood Cancer & Research Centers ( Site 0541)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0369)

location_facility: Windsor Regional Cancer Program ( Site 0404)

location_facility: Centre Hospitalier de la Cote Basque ( Site 0173)

location_facility: Xiangya Hospital of Central South University ( Site 0115)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0341)

location_facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 0381)

location_facility: City Clinical Hosp.4 of DCC ( Site 0338)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0217)

location_facility: National Taiwan University Hospital ( Site 0088)

location_facility: Centrum Medyczne Pratia Ostroleka ( Site 0242)

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II ( Site 0253)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0266)

location_facility: Ospedale Santa Maria delle Croci ( Site 0232)

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0026)

location_facility: Beijing Chest Hospital Capital Medical University ( Site 0111)

location_facility: Hospital Tengku Ampuan Afzan ( Site 0062)

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0202)

location_facility: Tudogyogyintezet Torokbalint ( Site 0205)

location_facility: Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 0331)

location_facility: Central Texas Veterans Healthcare System ( Site 0533)

location_facility: McGill University Health Centre ( Site 0418)

location_facility: Seoul National University Bundang Hospital ( Site 0075)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0402)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 0517)

location_facility: Billings Clinic Cancer Center ( Site 0508)

location_facility: Oaxaca Site Management Organization SC ( Site 0389)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0263)

location_facility: Hospital General de Medellin Luz Castro de Gutierrez ( Site 0368)

location_facility: Samsun Medical Park Hastanesi ( Site 0320)

location_facility: Aichi Cancer Center Hospital ( Site 0018)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 0316)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 0321)

location_facility: Osaka International Cancer Institute ( Site 0019)

location_facility: Presidio Ospedaliero San Vincenzo ( Site 0231)

location_facility: National Taiwan University Hospital Hsin-Chu Branch ( Site 0087)

location_facility: The First Hospital of Jilin University ( Site 0110)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0090)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0113)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0027)

location_facility: Wollongong Private Hospital ( Site 0005)

location_facility: Ballarat Oncology and Haematology Services ( Site 0008)

location_facility: Ukranian Center of TomoTherapy ( Site 0344)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0207)

location_facility: Podillya Regional Center of Oncology ( Site 0343)

location_facility: Juntendo University Hospital ( Site 0029)

location_facility: Zhongshan Hospital Fudan University ( Site 0100)


acronym: Pembrolizumab plus Lenvatinib as First-line Intervention for Advanced Melanoma

title: A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Canada
Switzerland
Sweden
Korea, Republic of
United States
Chile
China
France
Israel
South Africa
Germany

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0281)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0425)

location_facility: Fudan University Shanghai Cancer Center ( Site 0607)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0273)

location_facility: Centre Hospitalier Victor Dupouy ( Site 0012)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0278)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 0181)

location_facility: Istituto Europeo di Oncologia ( Site 0067)

location_facility: Severance Hospital Yonsei University Health System ( Site 0552)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0064)

location_facility: University of Colorado Cancer Center ( Site 0708)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0189)

location_facility: LKH Universitatsklinikum Graz ( Site 0776)

location_facility: The First Hospital Of Jilin University ( Site 0603)

location_facility: Fujian Provincial Cancer Hospital ( Site 0612)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0553)

location_facility: Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 0182)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0041)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 0190)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0308)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0061)

location_facility: The Angeles Clinic and Research Institute ( Site 0707)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0007)

location_facility: Universitaetsspital Zuerich ( Site 0092)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0042)

location_facility: Hadassah Ein Karem Hebrew University Medical Center ( Site 0305)

location_facility: Seoul National University Hospital ( Site 0554)

location_facility: CHU de la Miletrie Poitiers ( Site 0011)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0805)

location_facility: OHSU Center for Health & Healing ( Site 0731)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0003)

location_facility: Instituto Nacional de Cancer Hospital do Cancer II ( Site 0394)

location_facility: Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 0036)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0803)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0191)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0033)

location_facility: Klinik fur Dermatologie Allergologie und Venerologie ( Site 0035)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0397)

location_facility: St. Vincent Frontier Cancer Center ( Site 0724)

location_facility: Melanoma Institute Australia ( Site 0452)

location_facility: Hospital Universitario La Paz ( Site 0184)

location_facility: Princess Alexandra Hospital ( Site 0454)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0004)

location_facility: Minnesota Oncology Specialist, PA ( Site 0766)

location_facility: Universitaetsklinikum Erlangen ( Site 0044)

location_facility: Sunnybrook Research Institute ( Site 0654)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0272)

location_facility: Baptist MD Anderson Cancer Center ( Site 0767)

location_facility: Hospital Universitario Carlos Haya ( Site 0186)

location_facility: John Wayne Cancer Institute ( Site 0706)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0661)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0802)

location_facility: McGill University Health Centre ( Site 0651)

location_facility: Azienda Ospedaliera Universitaria Senese ( Site 0065)

location_facility: California Pacific Medical Center Research Institute ( Site 0705)

location_facility: Hospital Sao Vicente de Paulo ( Site 0396)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 0126)

location_facility: Karolinska Universitetssjukhuset ( Site 0211)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0422)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0602)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 0426)

location_facility: Inova Schar Cancer Institute ( Site 0739)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0212)

location_facility: University of North Carolina - Cancer Hospital ( Site 0751)

location_facility: Hospital de Caridade de Ijui ( Site 0391)

location_facility: PERSONAL - Oncologia de Precisao e Personalizada ( Site 0399)

location_facility: Universitaetsklinikum Leipzig ( Site 0040)

location_facility: Norrlands Universitetssjukhus ( Site 0216)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0183)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0421)

location_facility: Nanjing Drum Tower Hospital ( Site 0609)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 0606)

location_facility: Hospital Duran i Reinals ICO de Hospitalet ( Site 0187)

location_facility: Medizinische Universitat Wien ( Site 0778)

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma.

The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.


title: A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe

acronym: EU-CAPTURE

summary: The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.

ReferenceCitation: Vencio S, Vianna AGD, da Silva MACF, Precoma DB. Contemporary (2019) prevalence of cardiovascular disease in adults with type 2 diabetes in Brazil: the cross-sectional CAPTURE study. Diabetol Metab Syndr. 2022 Jan 10;14(1):5. doi: 10.1186/s13098-021-00775-9.

ReferenceCitation: Mosenzon O, Alguwaihes A, Leon JLA, Bayram F, Darmon P, Davis TME, Dieuzeide G, Eriksen KT, Hong T, Kaltoft MS, Lengyel C, Rhee NA, Russo GT, Shirabe S, Urbancova K, Vencio S; CAPTURE Study Investigators. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021 Jul 27;20(1):154. doi: 10.1186/s12933-021-01344-0.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country: France Italy Czechia

intervention_type: Other