lead_sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit

summary: This study will evaluate the role of addition of an anti-angiogenic agent (Nintedanib/placebo) to conventional combination chemotherapy as concomitant and maintenance treatment in primary advanced or with first relapse of endometrial cancer.

sponsor_collaborators: North Eastern German Society of Gynaecological Oncology

location_facility: Universitätsfrauenklinik am Klinikum Südstadt Rostock

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: St. Vincentius-Kliniken gAG Frauenklinik mit Hebammenlehranstalt

location_facility: Hospital Group Diaconesses Croix Saint-Simon

title: ENGOT-EN1/FANDANGO: A Randomized Phase II Trial of First-line Combination Chemotherapy With Nintedanib / Placebo for Patients With Advanced or Recurrent Endometrial Cancer

ipd_sharing_description: Upon request.

location_country: Finland Germany Norway Denmark Sweden Belgium France


title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

summary: This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Axovant Sciences Ltd.

location_country:
Italy
United Kingdom
Netherlands
United States
Spain
Canada
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: PRONOUNCE

lead_sponsor: Ferring Pharmaceuticals

summary: The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.

ReferenceType: derived

ReferenceCitation: Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30. Erratum In: Circulation. 2021 Oct 19;144(16):e273.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

version: acceptedVersion

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

repository_institution: University of California - eScholarship University of California

version: submittedVersion

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

oa_host_type: repository

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

sponsor_collaborators:
Ferring Pharmaceuticals
Memorial Sloan Kettering Cancer Center
Duke Clinical Research Institute

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Urology Associates Urologic Medical Research

location_facility: Groote Schuur Hospital Department of Urology

location_facility: Urologic Consultants of Southeaster PA LLP

location_facility: University of California, Irvine Medical Center

location_facility: University of Washington School of Medicine

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: University of Arizona College of Medicine

location_facility: Medical University of South Carolina (MUSC)

location_facility: FSBI "Moscow scientific research oncology institute"

location_facility: Staedtisches Klinikum Braunschweig GmbH - Standort Salzdahlumer

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.

location_facility: Advanced Urology Centers of New York Elmont Division

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: J. Giddens Medicine Professional Corporation

location_facility: Jewish General Hospital / McGill University

location_facility: Veterans Affairs Medical Center-Salisbury, NC

location_facility: Urological Associates of Southern Arizona

location_facility: SBHI of Sverdiovsk Region "Sverdiovsk Regional Clinical Hospital #1

location_facility: University General Hospital of Heraklion

location_facility: SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov"

location_facility: G. Kenneth Jansz Medicine Professional Corporation

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: FBHI Privolzhskiy District Medical Centre FMBA of Russia

location_facility: VA Greater Los Angeles Healthcare System

location_facility: BHI of Omsk region "Clinical Oncology Dispensary

status: Terminated

title: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

source: euctr

location_country:
Finland
Germany
Poland
Slovakia
United Kingdom
United States
Greece
South Africa
Czechia
Canada
Russian Federation
France

status_simplified: Unknown


lead_sponsor: Hoffmann-La Roche

summary: This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

ReferenceCitation: Lu S, Fang J, Wang Z, Fan Y, Liu Y, He J, Zhou J, Hu J, Xia J, Liu W, Shi J, Yi J, Cao L. Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer. Cancer Med. 2023 Feb;12(3):2666-2676. doi: 10.1002/cam4.5144. Epub 2022 Sep 2.

ReferenceCitation: Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.

oa_colors: green hybrid

evidence: open (via crossref license)

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: hybrid

publisher_dissemination: American Association for Cancer Research

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Tianjin Medical University General Hospital

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Polyclinique de Limoges - Site Chenieux; Oncologie Medicale

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: First Hospital of China Medical University

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

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

location_facility: C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Anhui Provincial Hospital; 2F,Tumor chemotherapy Department

location_facility: Hopital d Instruction des Armees de Sainte Anne

location_facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Hospital CUF Porto; Servico de Imunoalergologia

location_facility: Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

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

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Niigata University Medical & Dental Hospital

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

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

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Gartnavel General Hospital; Beatson West of Scotland Cancer Centre

location_facility: HealthCare Research Network II, LLC - PPDS

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

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: Virginia Cancer Specialists (Fairfax) - USOR

location_facility: Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller

location_facility: Sydney Adventist Hospital; Clinical Trial Unit

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department

location_facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: Anhui Provincial Hospital; Respiratory Department

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept

location_facility: Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: University of Kentucky; Markey Cancer Center

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Advanced Medical and Dental Institute; Kompleks Klinikal

title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

type: EudraCT Number

location_country:
Ireland
Argentina
Australia
Japan
Chile
France
Lithuania
Portugal
Hungary
United States
Latvia
Ukraine
Romania
Belgium
China
Malaysia
Peru
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


type: Other Identifier

title: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

summary: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ReferenceCitation: Sullivan WG, Hatswell AJ. Letter re: 'Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications'. ESMO Open. 2021 Dec;6(6):100282. doi: 10.1016/j.esmoop.2021.100282. Epub 2021 Oct 28. No abstract available.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Doebele RC, Perez L, Trinh H, Martinec M, Martina R, Riehl T, Krebs MG, Meropol NJ, Wong WB, Crane G. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. J Comp Eff Res. 2021 Dec;10(17):1271-1282. doi: 10.2217/cer-2021-0131. Epub 2021 Aug 24. Erratum In: J Comp Eff Res. 2022 May;11(7):545-548.

oa_host_type: publisher

evidence: open (via page says license)

repositories_concat: closed

publisher_dissemination: Becaris Publishing Limited

ReferenceCitation: Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. doi: 10.1200/JCO.20.03025. Epub 2021 Mar 1.

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

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. doi: 10.1016/S1470-2045(19)30690-4. Epub 2019 Dec 11. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341.

repository_institution: PubMed Central - Europe PMC

repository_institution: Yonsei University Medical Library - YUHSpace

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)
UCL Discovery
ir.ymlib.yonsei.ac.kr

repositories_concat: PubMed Central;Pure (Denmark);UCL Discovery;ir.ymlib.yonsei.ac.kr

repositories_institution: Yonsei University Medical Library - YUHSpace

ReferenceCitation: Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum In: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Sigal D, Tartar M, Xavier M, Bao F, Foley P, Luo D, Christiansen J, Hornby Z, Maneval EC, Multani P. Activity of Entrectinib in a Patient With the First Reported NTRK Fusion in Neuroendocrine Cancer. J Natl Compr Canc Netw. 2017 Nov;15(11):1317-1322. doi: 10.6004/jnccn.2017.7029.

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

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Dignity Health St Joseph's Hospital and Medical Center

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology

location_facility: Institut de Recherche en Cancérologie de Montpellier

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

location_facility: Advocate Medical Group - Park Ridge, Luther Lane - Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Niigata Cancer Center Hospital; Internal Medicine

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics

location_facility: Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica

location_facility: Weinberg Cancer Institution at Franklin Square

location_facility: Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit

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

location_facility: National University Hospital; Haematology/Oncology

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Univ Of California Irvine College Of Medicine; 300194620

location_facility: Cancer Treatment Centers of America; Tulsa

location_facility: University of Michigan Comprehensive Cancer Center; Clinical Trials Office

location_facility: Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

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

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

location_facility: NHO Shikoku Cancer Center; Dept of Respiratory Medicine

location_facility: National Cancer Center Hospital; Dept of Respiratory Medicine

location_facility: Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs

location_facility: Universitaetsklinikum Koeln; Innere Medizin I, Haematologie

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Institut Gustave Roussy; Pathologie Thoracique

location_facility: Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hospital Universitario Ramon y Cajal; Servicio de Farmacia

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

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Shizuoka Cancer Center; Respiratory Internal Medicine

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hyogo Cancer Center, Dept of Respiratory Medicine

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: NCT Uniklinikum Heidelberg; Medizinische Onkologie

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

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: University of Southern California Medical Center

location_facility: Miyagi Cancer Center; Respiratory Medicine

location_facility: University of California San Diego Moores Cancer Center; Dept of Lung Cancer

location_facility: Università Campus Bio-Medico di Roma; Oncologia Medica


title: A Phase 1, Open-Label, Non-Randomized, Safety, Tolerability and Pharmacokinetic Study of TAS3681 in Patients With Metastatic Castration Resistant Prostate Cancer

summary: The purpose of this trial is to investigate the safety and tolerability of TAS3681, to find the maximum tolerated dose (MTD)/recommended dose of TAS3681 (Escalation Phase) and to further evaluate safety and preliminary efficacy of TAS3681 at the MTD/recommended dose (Expansion Phase).

ipd_sharing: No

lead_sponsor: Taiho Oncology, Inc.

location_country:
United States
Spain
United Kingdom
France

location_facility: Univeristy of California Davis Comprehensive Cancer Center

location_facility: Royal Marsden Hospital (RMH) NHS Foundation Trust (DDU)

location_facility: Florida Cancer Specialists & Research Institute

location_facility: The Christie NHS Foundation Trust- The Christie Clinic

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: Cambridge University Hospitals NHS Foundation

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: GU Research Network / Urology Cancer Center

location_facility: Institut Catala d Oncologia - L Hospitalet de Llobregat

location_facility: UMMC-Cancer Center and Research Institute

status_simplified: Ongoing


acronym: KESTREL

lead_sponsor: AstraZeneca

summary: This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.

ReferenceCitation: Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. No abstract available. Erratum In: Lancet Oncol. 2021 Apr;22(4):e134.

oa_host_type: closed

title: A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

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

location_country:
Germany
Poland
Japan
Brazil
Thailand
Vietnam
Canada
France
Slovakia
United States
Ukraine
India
Romania
Belgium
Philippines
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation

ipd_sharing: Yes


acronym: MIRROS

summary: This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.

ReferenceCitation: Montesinos P, Beckermann BM, Catalani O, Esteve J, Gamel K, Konopleva MY, Martinelli G, Monnet A, Papayannidis C, Park A, Recher C, Rodriguez-Veiga R, Rollig C, Vey N, Wei AH, Yoon SS, Fenaux P. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine +/- idasanutlin in relapsed or refractory acute myeloid leukemia. Future Oncol. 2020 May;16(13):807-815. doi: 10.2217/fon-2020-0044. Epub 2020 Mar 13.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

publisher_dissemination: Future Science Ltd

location_facility: M.D. Anderson Cancer Center; Department of Hematology

location_facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III

location_facility: Helsinki University Central Hospital; Hematology

location_facility: Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie

location_facility: Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

location_facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

location_facility: Shaare Zedek Medical Center; Hematology Dept.

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Centre Hospitalier Uni Ire; Service Des Maladies Du Sang

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: IRCCS AOU S.Martino; Clinica Ematologica

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

location_facility: Geelong Hospital; Andrew Love Cancer Centre

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

location_facility: Universitätsklinikum Marburg Zentrum f. Innere Medizin

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: Juravinski Cancer Clinic; Clinical Trials Department

location_facility: Concord Repatriation General Hospital; Haematology

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Rabin Medical Center-Beilinson Campus;Hematology-Oncology

location_facility: Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

location_facility: Institut J Paoli I Calmettes; Onco Hematologie 2

location_facility: Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation

location_facility: Hadassah Ein Karem Hospital; Haematology

location_facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health

location_facility: Canberra Hospital; Haematology Department

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie

location_facility: HOPITAL SAINT ANTOINE;Hematologie Clinique

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

location_country:
Finland
Germany
New Zealand
Australia
Canada
France
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Panama
Russian Federation
Israel


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection

summary: The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.

ReferenceCitation: O'Neil B, Ison MG, Hallouin-Bernard MC, Nilsson AC, Torres A, Wilburn JM, van Duijnhoven W, Van Dromme I, Anderson D, Deleu S, Kosoglou T, Vingerhoets J, Rossenu S, Leopold L. A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination With Oseltamivir in Elderly and Nonelderly Adults Hospitalized With Influenza A Infection: OPAL Study. J Infect Dis. 2022 Aug 12;226(1):109-118. doi: 10.1093/infdis/jiaa376.

publisher_dissemination: Oxford University Press

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
New Zealand
Hong Kong
Singapore
Australia
Brazil
Netherlands
Sweden
Belgium
United States
Spain
Malaysia
Turkey
Canada
France


title: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer

summary: A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

ReferenceCitation: Powles T, van der Heijden MS, Castellano D, Galsky MD, Loriot Y, Petrylak DP, Ogawa O, Park SH, Lee JL, De Giorgi U, Bogemann M, Bamias A, Eigl BJ, Gurney H, Mukherjee SD, Fradet Y, Skoneczna I, Tsiatas M, Novikov A, Suarez C, Fay AP, Duran I, Necchi A, Wildsmith S, He P, Angra N, Gupta AK, Levin W, Bellmunt J; DANUBE study investigators. Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1574-1588. doi: 10.1016/S1470-2045(20)30541-6. Epub 2020 Sep 21. Erratum In: Lancet Oncol. 2021 Jan;22(1):e5.

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

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

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

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


title: A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration

acronym: Proxima A

summary: This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study is also intended to generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 48 months. There is a planned interim analysis around the 2-year time window for the study.

study_type: Observational

location_country:
Germany
Italy
Poland
Hungary
Argentina
Israel
Australia
Brazil
United Kingdom
Austria
United States
Spain
Greece
Canada
France

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: University of North Carolina; Kittner Eye Center

location_facility: Clinique de la Louviere - Nord retine; Maladie et chirurgie des Yeux

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: Northern Beaches Retina Cataract Glaucoma

location_facility: Centre ophtalmologique Rabelais; Ophtalmologie

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Soroka university medical center; Ophtalmology

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: University General Hospital of Heraklion; Department of Ophthalmology

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: Centres Ophtalmologique St Exupéry; Ophtalmologie

location_facility: Università degli Studi dell'Insubria; Clinica Oculistica

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica

location_facility: Pinderfields Hospital; Clinical Research Team, Rowan House

location_facility: Hospital Universitario Virgen de la Macarena; Servicio de Oftalmologia

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia

location_facility: Newcastle Eye Hospital Research Foundation

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: European Interbalkan Medical Center; Ophthalmology Dpt

location_facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie, Zaklad Patologii Ogolnej PUM"

location_facility: John Radcliffe Hospital; Oxford Eye Hospital

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

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

location_facility: CHU Poitiers - CHR La Miletrie; Ophtalmologie

intervention_type: Other


acronym: ACCUTE

lead_sponsor: Atox Bio Ltd

summary: The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.

ReferenceType: result

ReferenceCitation: Bulger EM, May AK, Robinson BRH, Evans DC, Henry S, Green JM, Toschlog E, Sperry JL, Fagenholz P, Martin ND, Dankner WM, Maislin G, Wilfret D, Bernard AC; ACCUTE Study Investigators. A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103). Ann Surg. 2020 Sep 1;272(3):469-478. doi: 10.1097/SLA.0000000000004102.

sponsor_collaborators: Biomedical Advanced Research and Development Authority

location_facility: Texas Tech University Health Sciences Center at El Paso

location_facility: Baylor College of Medicine-Ben Taub Hospital

location_facility: Our Lady of the Lake Regional Medical Center

location_facility: University of Minnesota Medical Center-Fairview

location_facility: Wright State University & Premier Health Clinical Trials Research Alliance

location_facility: Wayne State University-Sinai Grace Hospital

location_facility: Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

location_facility: University of California, Davis Medical Center

location_facility: Erie County Medical Center-Affliate of SUNYat Buffalo

location_facility: Medical College of Wisconsin-Froedtert Hospital

location_facility: University of Texas Health Science Center at San Antonio

location_facility: University of Maryland R Adams Cowley Shock Trauma Center

location_facility: Emory University at Grady Memorial Hospital

location_facility: University of Arkansas for Medical Sciences

location_facility: The Pennsylvania State University and The Milton S. Hershey Medical Center

location_facility: Wayne State University-Detroit Receiving Hospital

location_facility: Ryder Trauma Center/Jackson Memorial Hospital

location_facility: Staten Island University Hospital-Northwell Health

location_facility: University of Cincinnati Medical Center (UCMC)

title: Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)

location_country:
United States
France


title: An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

summary: The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

primary_purpose: Other

ReferenceCitation: Bahit MC, Vora AN, Li Z, Wojdyla DM, Thomas L, Goodman SG, Aronson R, Jordan JD, Kolls BJ, Dombrowski KE, Vinereanu D, Halvorsen S, Berwanger O, Windecker S, Mehran R, Granger CB, Alexander JH, Lopes RD. Apixaban or Warfarin and Aspirin or Placebo After Acute Coronary Syndrome or Percutaneous Coronary Intervention in Patients With Atrial Fibrillation and Prior Stroke: A Post Hoc Analysis From the AUGUSTUS Trial. JAMA Cardiol. 2022 Jul 1;7(7):682-689. doi: 10.1001/jamacardio.2022.1166.

publisher_dissemination: American Medical Association

ReferenceCitation: Welsh RC, Dehghani P, Lopes R, Wojdyla DM, Aronson R, Granger CB, Windecker S, Vora AN, Vinereanu D, Halvorsen S, Parkhomenko A, Mehran R, Alexander JH, Goodman S. Impact of prior oral anticoagulant use and outcomes on patients from secondary analysis in the AUGUSTUS trial. Open Heart. 2022 Feb;9(1):e001892. doi: 10.1136/openhrt-2021-001892.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Oslo - Duo Research Archive

repositories_concat: PubMed Central;www.duo.uio.no

publisher_dissemination: British Medical Journal

ReferenceCitation: Harskamp RE, Fanaroff AC, Lopes RD, Wojdyla DM, Goodman SG, Thomas LE, Aronson R, Windecker S, Mehran R, Granger CB, Alexander JH. Antithrombotic Therapy in Patients With Atrial Fibrillation After Acute Coronary Syndromes or Percutaneous Intervention. J Am Coll Cardiol. 2022 Feb 8;79(5):417-427. doi: 10.1016/j.jacc.2021.11.035.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Hijazi Z, Alexander JH, Li Z, Wojdyla DM, Mehran R, Granger CB, Parkhomenko A, Bahit MC, Windecker S, Aronson R, Berwanger O, Halvorsen S, de Waha-Thiele S, Sinnaeve P, Darius H, Storey RF, Lopes RD. Apixaban or Vitamin K Antagonists and Aspirin or Placebo According to Kidney Function in Patients With Atrial Fibrillation After Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2021 Mar 23;143(12):1215-1223. doi: 10.1161/CIRCULATIONAHA.120.051020. Epub 2021 Jan 19.

ReferenceCitation: Alexander JH, Wojdyla D, Vora AN, Thomas L, Granger CB, Goodman SG, Aronson R, Windecker S, Mehran R, Lopes RD. Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS. Circulation. 2020 May 19;141(20):1618-1627. doi: 10.1161/CIRCULATIONAHA.120.046534. Epub 2020 Mar 29.

ReferenceCitation: Lopes RD, Leonardi S, Wojdyla DM, Vora AN, Thomas L, Storey RF, Vinereanu D, Granger CB, Goodman SG, Aronson R, Windecker S, Thiele H, Valgimigli M, Mehran R, Alexander JH. Stent Thrombosis in Patients With Atrial Fibrillation Undergoing Coronary Stenting in the AUGUSTUS Trial. Circulation. 2020 Mar 3;141(9):781-783. doi: 10.1161/CIRCULATIONAHA.119.044584. Epub 2019 Nov 11. No abstract available.

ReferenceCitation: Windecker S, Lopes RD, Massaro T, Jones-Burton C, Granger CB, Aronson R, Heizer G, Goodman SG, Darius H, Jones WS, Aschermann M, Brieger D, Cura F, Engstrom T, Fridrich V, Halvorsen S, Huber K, Kang HJ, Leiva-Pons JL, Lewis BS, Malaga G, Meneveau N, Merkely B, Milicic D, Morais J, Potpara TS, Raev D, Sabate M, de Waha-Thiele S, Welsh RC, Xavier D, Mehran R, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial. Circulation. 2019 Dec 3;140(23):1921-1932. doi: 10.1161/CIRCULATIONAHA.119.043308. Epub 2019 Sep 26.

ReferenceCitation: Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, Averkov O, Bahit MC, Berwanger O, Budaj A, Hijazi Z, Parkhomenko A, Sinnaeve P, Storey RF, Thiele H, Vinereanu D, Granger CB, Alexander JH; AUGUSTUS Investigators. Antithrombotic Therapy after Acute Coronary Syndrome or PCI in Atrial Fibrillation. N Engl J Med. 2019 Apr 18;380(16):1509-1524. doi: 10.1056/NEJMoa1817083. Epub 2019 Mar 17.

evidence: open (via free article)

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-Label, 2 x 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: Rationale and design of the AUGUSTUS trial. Am Heart J. 2018 Jun;200:17-23. doi: 10.1016/j.ahj.2018.03.001. Epub 2018 Mar 9.

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

sponsor_collaborators:
Bristol-Myers Squibb
Pfizer
Duke Clinical Research Institute

location_country:
Germany
Poland
Argentina
Australia
Brazil
Croatia
Chile
Czechia
Canada
Virgin Islands (U.S.)
Serbia
France
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
Peru
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Bulgaria
Russian Federation
Israel

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Advocate Medical Group ? Cardiology and Pulmonology

location_facility: University of Iowa Stead Family Children's Hospital

location_facility: Cardiovascular Associates of the Southeast, LLC

location_facility: Clinical Trials of America-NC, LLC - PPDS

location_facility: Carolina Cardiology Clinical Research Institute

location_facility: New York-Presbyterian Brooklyn Methodist Hospital

location_facility: Clinical Trials of America LA LLC - PPDS

location_facility: Hudson Valley Cardiovascular Practice, PC

location_facility: Knoxville Health Managment Associates Cardiology PPM LLC

location_facility: University of North Carolina School of Medicine

location_facility: Clearwater Cardiovascular and Interventional Consultants

location_facility: Caprock Cardiac Center Research Institute

location_facility: Duke Cardiology and Cardiovascular Surgery of Lumberton


acronym: Study of oral cMET inhibitor INC280 in patients with EGFR wild-type, advanced NSCLC

lead_sponsor: Novartis Pharmaceuticals

summary: A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC) as measured by overall response rate (ORR). The study will also evaluate safety and pharmacokinetics of INC280.

ReferenceCitation: Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, Heist RS; GEOMETRY mono-1 Investigators. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. doi: 10.1056/NEJMoa2002787.

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

repository_institution: Leiden University - Leiden Repository

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

publisher_dissemination: Massachusetts Medical Society

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: University of California Irvine Medical Center Chao Family Chao Family Comp Cancer Center

location_facility: University of Iowa Hospitals & Clinics SC-3

location_facility: Cancer Therapy and Research Center UT Health Science Center SC-5

location_facility: VA Ann Arbor Health System VA Ann Arbor Health System

location_facility: NKI-AVL, Department of Thoracic-Oncology

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: University of Utah / Huntsman Cancer Institute Oncology

location_facility: Massachusetts General Hospital MGH Cancer Center

title: A Phase II, Multicenter Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC)(Geometry Mono-1)

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

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

location_country:
Germany
Argentina
Japan
France
United States
Lebanon
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


summary: This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.

ReferenceCitation: Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346.

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Kobe City Medical Center General Hospital; Respiratory Medicine

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

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

location_facility: Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

location_facility: Nagoya University Hospital; Respiratory Medicine

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

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

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Federal State Institution Medical Radiology Research Center

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

location_facility: Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica

location_facility: Harbin Medical University Tumor Hospital

location_facility: Azienda Ospedaliera Istituti Ospitalieri

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira

location_facility: Saint Petersburg Clinical Hospital of the Russian Academy of Sciences

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Tokyo Medical University Hospital; Dept of Surgery

location_facility: Azienda Socio Sanitaria Territoriale ? ASST di Monza

location_facility: Vanderbilt University Medical Center; Multiple Sclerosis Center

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

location_facility: Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: Teo Health SA - Saint Constantin Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Georgios Papanikolaou General Hosp. of Thessaloniki

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

location_facility: Ibaraki Prefectural Central Hospital; Division of respiratory

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

location_facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Centre Hospitalier Regional La Reunion Site Felix Guyon

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Hospital d Instructions des Armees Percy

location_facility: Private Enterprise Private Manufacturing Company Acinus

title: A Phase III, Open Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum Agent (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD-L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous Or Squamous Non-Small Cell Lung Cancer

location_country:
Germany
Poland
Japan
Brazil
Thailand
Turkey
Serbia
France
Hungary
United States
Ukraine
Romania
China
Italy
United Kingdom
Korea, Republic of
Spain
Greece
Russian Federation


lead_sponsor: Amgen

summary: B-precursor ALL is an aggressive malignant disease. Therapy is usually stratified according to risk characteristics to ensure that appropriate treatment is administered to patients with high-risk of relapse. In general, pediatric treatment regimens are more intense than those employed in adults and include courses of combination chemotherapy. Standard of care chemotherapy is associated with considerable toxicity. There is a lack of novel treatment options for subjects who relapse or are refractory to treatment. Therefore, innovative therapeutic approaches are urgently needed. Blinatumomab is a bispecific single-chain antibody construct designed to link B cells and T cells resulting in T cell activation and a cytotoxic T cell response against CD19 expressing cells. This study will evaluate the event-free survival (EFS) after treatment with blinatumomab when compared to standard of care (SOC) chemotherapy. The effect of blinatumomab on overall survival and reduction of minimal residual disease compared to SOC chemotherapy will also be investigated.

ReferenceType: background

ReferenceCitation: Locatelli F, Eckert C, Hrusak O, Buldini B, Sartor M, Zugmaier G, Zeng Y, Pilankar D, Morris J, von Stackelberg A. Blinatumomab overcomes poor prognostic impact of measurable residual disease in pediatric high-risk first relapse B-cell precursor acute lymphoblastic leukemia. Pediatr Blood Cancer. 2022 Aug;69(8):e29715. doi: 10.1002/pbc.29715. Epub 2022 Apr 28.

ReferenceCitation: Blinatumomabe em pacientes pediátricos com leucemia linfoblástica aguda B em primeira recidiva de alto risco: um estudo de custo-efetividade. van Beurden-Tan CHY, Ribeiro RA, Seber A, de Martino Lee ML, Marçola M, Schuetz R, Loggetto SR, Maiolino A. Jornal Brasileiro de Economia da Saúde 14(1): 41-50. 10.21115/JBES.v14.n1.p41-50

ReferenceCitation: Locatelli F, Zugmaier G, Rizzari C, Morris JD, Gruhn B, Klingebiel T, Parasole R, Linderkamp C, Flotho C, Petit A, Micalizzi C, Mergen N, Mohammad A, Kormany WN, Eckert C, Moricke A, Sartor M, Hrusak O, Peters C, Saha V, Vinti L, von Stackelberg A. Effect of Blinatumomab vs Chemotherapy on Event-Free Survival Among Children With High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia: A Randomized Clinical Trial. JAMA. 2021 Mar 2;325(9):843-854. doi: 10.1001/jama.2021.0987.

ReferenceCitation: Locatelli F, Zugmaier G, Rizzari C, Morris JD, Gruhn B, Klingebiel T, Parasole R, Linderkamp C, Flotho C, Petit A, Micalizzi C, Zeng Y, Desai R, Kormany WN, Eckert C, Moricke A, Sartor M, Hrusak O, Peters C, Saha V, Vinti L, von Stackelberg A. Improved survival and MRD remission with blinatumomab vs. chemotherapy in children with first high-risk relapse B-ALL. Leukemia. 2023 Jan;37(1):222-225. doi: 10.1038/s41375-022-01770-3. Epub 2022 Dec 8. No abstract available.

title: Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Czechia
France
Portugal
Denmark
Switzerland
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Russian Federation
Israel


summary: This randomized, open-label study will evaluate the safety and efficacy of atezolizumab (MPDL3280A) in combination with carboplatin + paclitaxel or carboplatin + nab-paclitaxel compared with treatment with carboplatin + nab-paclitaxel in chemotherapy-naive participants with Stage IV squamous NSCLC.

ReferenceCitation: Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Kyoto University Hospital, Respiratory Medicine

location_facility: IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Kobe City Medical Center General Hospital; Respiratory Medicine

location_facility: Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service Pharmacie Essais Cliniques

location_facility: Instituto Regional de Enfermedades Neoplásicas Del Norte

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

location_facility: Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary; Surgery Department #1

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: MI of the Lviv Regional Council Lviv Oncology Regional Treatment and Diagnostic Centre; Chemotherapy

location_facility: National Cancer Center Hospital East; Thoracic Oncology

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Nagoya University Hospital; Respiratory Medicine

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: VU Medisch Centrum; VU University Medical Center

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Kanagawa Cancer Center;Thoracic Oncology

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

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

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

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

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

location_facility: Shizuoka Cancer Center; Thoracic Oncology

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Saitama Cancer Center; Thoracic Oncology

location_facility: Hospital General Universitario de Valencia

location_facility: Tokyo Medical University Hospital; Dept of Surgery

location_facility: Catharina Hospital; Afdeling Longgeneeskunde en Tuberculose

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Kaiser Permanente - Sacramento Medical Center and Medical Offices

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Centro de Investigacion; Clinica - Clinica Viedma S.A.

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Azienda Ospedaliero Universitaria Seconda Università degli Studi di Napoli; Farmacia Centralizzata

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Cenantron - Centro Avancado de Tratamento Oncologico

location_facility: Maryland Oncology Hematology (Lanham) - USOR

location_facility: National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ESSALUD

location_facility: MNPE Zaporizhzhia Regional Antitumor Center ZRC

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: National Hospital Organization Shikoku Cancer Center; Internal Medicine

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

location_facility: Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: Universität Des Saarlandes; Klinik für Innere Medizin V

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Niigata University Medical & Dental Hospital; Respiratory Medicine and Infectious Disease

location_facility: SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Southcoast Health System; Southcoast Centers For Cancer Care

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: Osaka City Uni Hospital; Respiratory Medicine

title: A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel or Atezolizumab in Combination With Carboplatin+Nab-Paclitaxel Versus Carboplatin+Nab-Paclitaxel in Chemotherapy-Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

location_country:
Germany
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Lithuania
Portugal
Slovakia
United States
Latvia
Ukraine
Belgium
Peru
Italy
Singapore
Netherlands
Austria
Mexico
Spain
Taiwan
Bulgaria
Russian Federation
Israel


acronym: SANDPIPER

summary: This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

ReferenceCitation: Dent S, Cortes J, Im YH, Dieras V, Harbeck N, Krop IE, Wilson TR, Cui N, Schimmoller F, Hsu JY, He J, De Laurentiis M, Sousa S, Drullinsky P, Jacot W. Phase III randomized study of taselisib or placebo with fulvestrant in estrogen receptor-positive, PIK3CA-mutant, HER2-negative, advanced breast cancer: the SANDPIPER trial. Ann Oncol. 2021 Feb;32(2):197-207. doi: 10.1016/j.annonc.2020.10.596. Epub 2020 Nov 10.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: AZ. Usll12 Veneziana-Ospedale Dell'angelo;Oncologia Medica

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: St John of God Murdoch Hospital; Oncology West

location_facility: Memorial Sloan Kettering Cancer Center; Memorial Sloan Kettering; at Westchester

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Azienda USL 9 Grosseto; Dipartimento Politiche del Farmaco

location_facility: SHATOD Dr. Marko Antonov Markov-Varna, EOOD

location_facility: Regional Clinical Oncology Dispensary; Surgery Dept, Thoracic

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: John Theurer Cancer Ctr at Hackensack Univ Medical Ctr

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

location_facility: Hospital San Jose Del Tec. de Monterrey; Oncology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Hospital Garcia de Orta; Servico de Oncologia Medica

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: ARCISPEDALE S. MARIA NUOVA - REGGIO EMILIA; Struttura Semplice Coordinamento Breast Unit Integrata

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

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

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: University Hospital of Patras Medical Oncology

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Wojewodzki Szpital Specjalistyczny; Osrodek Badawczo-Rozwojowy, Oddzial Chemioterapii

location_facility: Mercy Hospitals East Communities d/b/a Mercy Hospital St. Louis

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Liverpool Hospital; Cancer Therapy Centre

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Complex Oncological Center - Plovdiv, EOOD

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: University Hospital; Oncology and Radiotherapy

location_facility: Oregon Health & Science University; Knight Cancer Institute, Community Hematology Oncology

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Pole de Cancerologie Prive Strasbourgeois

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Klinikum Mutterhaus der Borromäerinnen, Innere Medizin I

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

title: A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

location_country:
Finland
Germany
Poland
Australia
Bosnia and Herzegovina
Thailand
Turkey
Czechia
Canada
Serbia
France
Colombia
Portugal
United States
Romania
China
Peru
Italy
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden


title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre 24-week Study to Evaluate the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Eosinophilic Asthma on Markers of Asthma Control

summary:
This is a multi-centre, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in participants with severe eosinophilic asthma on markers of asthma control. The overall intent of the current study is to more fully explore the impact of mepolizumab on health-related quality of life (HR-QoL) and other measures of asthma control, including lung function.

Participants who meet the predefined criteria will be randomised to receive either mepolizumab or placebo in addition to standard of care asthma treatment. Approximately 780 participants with severe eosinophilic asthma will be screened to ensure the randomisation of 544 participants (272 participants per treatment group) into the study.

ReferenceCitation: Lemiere C, Taille C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.

publisher_dissemination: Springer-Nature

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

ReferenceCitation: Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

publisher_dissemination: Informa

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of >/=150-300 cells/muL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

ReferenceCitation: Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

repository_institution: Imperial College London - Spiral

ReferenceCitation: Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, Trevor JL, Magnan A, Ten Brinke A. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017 May;5(5):390-400. doi: 10.1016/S2213-2600(17)30125-X. Epub 2017 Apr 5.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Germany
Argentina
Czechia
Canada
France
Slovakia
United States
Ukraine
Belgium
Peru
Estonia
Italy
Norway
United Kingdom
Netherlands
Spain
Greece
Bulgaria
Russian Federation


lead_sponsor: Janssen R&D Ireland

summary: The purpose of this study is to demonstrate non-inferiority in efficacy while switching to a once-daily single-tablet regimen containing darunavir (DRV)/ cobicistat (COBI)/ emtricitabine (FTC)/ tenofovir alafenamide (TAF) (D/C/F/TAF tablet) relative to continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with tenofovir disoproxil fumarate (FTC/TDF) in virologically-suppressed (human immunodeficiency virus type 1 ribonucleic acid [HIV-1 RNA] concentrations less than [<] 50 copies per milliliter [copies/mL]) HIV-1 infected participants.

ReferenceCitation: Ackaert O, McDougall D, Perez-Ruixo C, Perez-Ruixo JJ, Jezorwski J, Crauwels HM. Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies). AAPS J. 2021 Jun 7;23(4):82. doi: 10.1208/s12248-021-00607-8.

ReferenceCitation: Huhn GD, Wilkin A, Mussini C, Spinner CD, Jezorwski J, El Ghazi M, Van Landuyt E, Lathouwers E, Brown K, Baugh B; AMBER and EMERALD study groups. Week 96 subgroup analyses of the phase 3, randomized AMBER and EMERALD trials evaluating the efficacy and safety of the once daily darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) single-tablet regimen in antiretroviral treatment (ART)-naive and -experienced, virologically-suppressed adults living with HIV-1. HIV Res Clin Pract. 2020 Dec;21(6):151-167. doi: 10.1080/25787489.2020.1844520. Epub 2021 Feb 2.

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

ReferenceCitation: Lathouwers E, Wong EY, Brown K, Baugh B, Ghys A, Jezorwski J, Mohsine EG, Van Landuyt E, Opsomer M, De Meyer S; AMBER and EMERALD Study Groups. Week 48 Resistance Analyses of the Once-Daily, Single-Tablet Regimen Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Adults Living with HIV-1 from the Phase III Randomized AMBER and EMERALD Trials. AIDS Res Hum Retroviruses. 2020 Jan;36(1):48-57. doi: 10.1089/AID.2019.0111. Epub 2019 Oct 21.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_normalized: HAL

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central
archive.ugent.be

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central;archive.ugent.be

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Huhn GD, Eron JJ, Girard PM, Orkin C, Molina JM, DeJesus E, Petrovic R, Luo D, Van Landuyt E, Lathouwers E, Nettles RE, Brown K, Wong EY. Darunavir/cobicistat/emtricitabine/tenofovir alafenamide in treatment-experienced, virologically suppressed patients with HIV-1: subgroup analyses of the phase 3 EMERALD study. AIDS Res Ther. 2019 Aug 29;16(1):23. doi: 10.1186/s12981-019-0235-1.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Audencia Business School

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

ReferenceCitation: Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, Eron JJ, Van Landuyt E, Lathouwers E, Hufkens V, Petrovic R, Vanveggel S, Opsomer M; EMERALD study group. Efficacy and safety of switching from boosted protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV. 2018 Jan;5(1):e23-e34. doi: 10.1016/S2352-3018(17)30179-0. Epub 2017 Oct 6.

title: A Phase 3, Randomized, Active-controlled, Open-label Study to Evaluate the Efficacy, Safety and Tolerability of Switching to a Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) Once-daily Single-tablet Regimen Versus Continuing the Current Regimen Consisting of a Boosted Protease Inhibitor (bPI) Combined With Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) in Virologically-suppressed, Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects

location_country:
Poland
United Kingdom
Sweden
Switzerland
Belgium
United States
Spain
Canada
Puerto Rico
France


title: A Phase 1b/3, Multicenter, Trial of Talimogene Laherparepvec in Combination With Pembrolizumab (MK-3475) for Treatment of Unresectable Stage IIIB to IVM1c Melanoma (MASTERKEY-265)

summary:
The primary objectives of the Phase 1b part of the study are to evaluate the safety, as assessed by incidence of dose limiting toxicity (DLT), of talimogene laherparepvec in combination with pembrolizumab in adults with previously untreated, unresectable, stage IIIB to IVM1c melanoma.

The primary objective of Phase 3 are to evaluate the efficacy of talimogene laherparepvec with pembrolizumab versus placebo with pembrolizumab, as assessed by progression-free survival (PFS) (response evaluation by blinded independent central review using modified Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) and overall survival (OS).

ReferenceCitation: Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, Olszanski AJ, Malvehy J, Cebon J, Fernandez E, Kirkwood JM, Gajewski TF, Chen L, Gorski KS, Anderson AA, Diede SJ, Lassman ME, Gansert J, Hodi FS, Long GV. Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy. Cell. 2017 Sep 7;170(6):1109-1119.e10. doi: 10.1016/j.cell.2017.08.027. Erratum In: Cell. 2018 Aug 9;174(4):1031-1032.

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.

ReferenceCitation: Chesney JA, Ribas A, Long GV, Kirkwood JM, Dummer R, Puzanov I, Hoeller C, Gajewski TF, Gutzmer R, Rutkowski P, Demidov L, Arenberger P, Shin SJ, Ferrucci PF, Haydon A, Hyngstrom J, van Thienen JV, Haferkamp S, Guilera JM, Rapoport BL, VanderWalde A, Diede SJ, Anderson JR, Treichel S, Chan EL, Bhatta S, Gansert J, Hodi FS, Gogas H. Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma. J Clin Oncol. 2023 Jan 20;41(3):528-540. doi: 10.1200/JCO.22.00343. Epub 2022 Aug 23.

ReferenceCitation: Watanabe D, Goshima F. Oncolytic Virotherapy by HSV. Adv Exp Med Biol. 2018;1045:63-84. doi: 10.1007/978-981-10-7230-7_4.

sponsor_collaborators:
Amgen
Merck Sharp & Dohme LLC

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Russian Federation


title: A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

summary: The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]).

ReferenceCitation: Saad F, Efstathiou E, Attard G, Flaig TW, Franke F, Goodman OB Jr, Oudard S, Steuber T, Suzuki H, Wu D, Yeruva K, De Porre P, Brookman-May S, Li S, Li J, Thomas S, Bevans KB, Mundle SD, McCarthy SA, Rathkopf DE; ACIS Investigators. Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study. Lancet Oncol. 2021 Nov;22(11):1541-1559. doi: 10.1016/S1470-2045(21)00402-2. Epub 2021 Sep 30.

lead_sponsor: Aragon Pharmaceuticals, Inc.

location_country:
Germany
United Kingdom
Argentina
Australia
Brazil
Japan
Mexico
Belgium
Netherlands
United States
Korea, Republic of
Spain
South Africa
Canada
Russian Federation
France


title: Trabectedin for Recurrent Grade II or III Meningioma: a Randomized Phase II Study of the EORTC Brain Tumor Group

summary: The aim of this study is to collect data on activity, toxicity and quality of life of trabectedin therapy in patients with recurrent high-grade meningioma.

ReferenceCitation: Hundsberger T, Surbeck W, Hader C, Putora PM, Conen K, Roelcke U. [Meningioma: management of the most common brain tumour]. Praxis (Bern 1994). 2016 Apr 13;105(8):445-51. doi: 10.1024/1661-8157/a002320. German.

publisher_dissemination: Hogrefe Publishing Group

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Germany
Italy
Norway
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Eberhard Karls Universitaet Tuebingen - Universitaetsklinikum Tuebingen

location_facility: Newcastle Hospitals NHS Trust - Freeman Hospital, Northern Centre For Cancer Care

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale San Giovanni - Dipartimento Neuroscienze

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie

location_facility: CHU de Lyon - CHU Lyon - Hopital neurologique Pierre Wertheimer

location_facility: Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital

location_facility: Istituto Oncologico Veneto IRCCS - Ospedale Busonera

location_facility: Medical University Vienna - General Hospital AKH

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

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

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Centre Hospitalier Universitaire Vaudois - Lausanne

location_facility: Istituto Regina Elena / Istituti Fisioterapici Ospitalieri

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: Spaarne Gasthuis - Vrije Universiteit Medisch Centrum

location_facility: CHU de Bordeaux - Groupe Hospitalier Saint-André - Hopital Saint-Andre

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Oslo University Hospital - Radiumhospitalet

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

location_facility: Guy's and St Thomas' NHS - St Thomas Hospital

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern