title: An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

summary: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

location_country:
Finland
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Norway
Canada
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Spain
Turkey

location_facility: Omsk Clinical Oncology Dispensary ( Site 1150)

location_facility: Masarykuv onkologicky ustav ( Site 0105)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 1300)

location_facility: Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 0610)

location_facility: Texas Oncology-Austin Central ( Site 1533)

location_facility: Fakultni nemocnice Hradec Kralove ( Site 0106)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 0408)

location_facility: Universitaetsklinikum Essen ( Site 0401)

location_facility: Hamamatsu University Hospital ( Site 1005)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650)

location_facility: Severance Hospital Yonsei University Health System ( Site 1202)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1000)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 0351)

location_facility: The University of Chicago Medical Center ( Site 1539)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 1655)

location_facility: Aarhus University Hospital Skejby ( Site 0250)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1155)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0004)

location_facility: Fakultni Thomayerova nemocnice ( Site 0107)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163)

location_facility: Azienda Ospedaliera Santa Maria ( Site 0602)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1251)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151)

location_facility: Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352)

location_facility: Universitaetsmedizin Berlin ( Site 0400)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0509)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513)

location_facility: Texas Oncology, P.A.-Dallas ( Site 1534)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702)

location_facility: Yamaguchi University Hospital ( Site 1018)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709)

location_facility: UCHealth Highlands Ranch Hospital ( Site 1560)

location_facility: Northwest Georgia Oncology Centers PC ( Site 1520)

location_facility: Kyiv City Clinical Oncology Center ( Site 1450)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 0603)

location_facility: Oncologos del Occidente S.A. ( Site 1708)

location_facility: Cambridge University Hospitals NHSFT ( Site 1405)

location_facility: Istituto Nazionale dei Tumori ( Site 0601)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0606)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0404)

location_facility: National Taiwan University Hospital ( Site 1100)

location_facility: The Christie NHS Foundation Trust ( Site 1401)

location_facility: Sapporo Medical University Hospital ( Site 1008)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0504)

location_facility: Centre Hospitalier Lyon Sud ( Site 0354)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1452)

location_facility: Oncology Hematology Care, Inc. ( Site 1524)

location_facility: Taipei Veterans General Hospital ( Site 1101)

location_facility: Administradora Country SA - Clinica del Country ( Site 1701)

location_facility: Oregon Health & Science University ( Site 1553)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 1254)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1402)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0410)

location_facility: Hospital Universitari Vall d Hebron ( Site 1250)

location_facility: Hadassah Medical-Oncology department ( Site 1164)

location_facility: Medical University of South Carolina ( Site 1518)

location_facility: SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159)

location_facility: Yokohama City University Hospital ( Site 1015)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152)

location_facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)

location_facility: BC Cancer - Vancouver Center ( Site 0155)

location_facility: Taichung Veterans General Hospital ( Site 1105)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 1104)

location_facility: Universitaetsklinik fuer Urologie ( Site 0405)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1850)

location_facility: CHU de Bordeaux Hop St ANDRE ( Site 0359)

location_facility: Hospital General Universitario 12 de Octubre ( Site 1252)

location_facility: Beth Israel Deaconess Medical Center ( Site 1501)

location_facility: Massachusetts General Hospital ( Site 1558)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1308)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)

location_facility: Korea University Anam Hospital ( Site 1203)

location_facility: St. Vincent Frontier Cancer Center ( Site 1549)

location_facility: Dana Farber Cancer Institute ( Site 1505)

location_facility: Chungnam National University Hospital ( Site 1205)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153)

location_facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1403)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350)

location_facility: Nippon Medical School Hospital ( Site 1010)

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306)

location_facility: Okayama University Hospital ( Site 1020)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 1703)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0102)

location_facility: Medical Oncology Ospedale San Donato ( Site 0609)

location_facility: Tokushima University Hospital-Department of Urology ( Site 1017)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 1651)

location_facility: Akershus universitetssykehus ( Site 0851)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)

location_facility: City clinical oncological dispensary ( Site 1154)

location_facility: Kuopion Yliopistollinen Sairaala ( Site 0304)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)

location_facility: Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)

location_facility: Saitama Medical University International Medical Center ( Site 1012)

location_facility: Centro Avancado de Tratamento Oncologico ( Site 1657)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 1411)

location_facility: Niigata University Medical & Dental Hospital ( Site 1022)

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 1160)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505)

location_facility: University of North Carolina at Chapel Hill ( Site 1537)

location_facility: National Cheng Kung University Hospital ( Site 1103)

location_facility: Ankara Universitesi Tip Fakultesi ( Site 1311)

location_facility: Norrlands Universitetssjukhus ( Site 1856)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 0607)

location_facility: National Cancer Center Hospital ( Site 1003)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)

location_facility: Tampereen yliopistollinen sairaala ( Site 0300)

location_facility: University of Rochester Medical Center ( Site 1543)

location_facility: Orszagos Onkologiai Intezet ( Site 0503)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1157)

location_facility: Sunnybrook Research Institute ( Site 0153)

location_facility: National Cancer Center Hospital East ( Site 1001)

location_facility: University of Alabama - Birmingham ( Site 1538)

location_facility: University of California San Diego Moores Cancer Center ( Site 1546)

location_facility: Princess Margaret Hospital. ( Site 1053)

location_facility: Nara Medical University Hospital ( Site 1009)

location_facility: TYKS T-sairaala Syopatautien pkl ( Site 0301)

location_facility: St Joseph Heritage Healthcare ( Site 1531)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0150)


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Poland
Thailand
Canada
Korea, Republic of
Hong Kong
Singapore
Hungary
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
New Zealand
Spain
Turkey

location_facility: Blokhin Cancer Research Center; Out-Patients Dept

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik

location_facility: Fraser Valley Centre British Columbia Cancer Agency

location_facility: The First Affiliated Hospital, Chongqing Medical University

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

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

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Uzsoki Utcai Korhaz; Onkoradiológiai Osztály

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

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

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

location_facility: Texas Oncology San Antonio Medical Center

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Narodowy Instytut Onkologii Odział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Providence Portland Medical Center; Providence Oncology and Hematology Clinic Westside

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Princess Alexandra Hospital; Oncology Department

location_facility: Universitätsfrauenklinik Ulm; Abteilung Gynäkologie

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Mount Vernon Hospital; Mount Vernon Cancer Centre

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kaiser Permanente;Clinical Trials Department

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Regional Oncology Dispensary; Dept of Chemotherapy

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Winship Cancer Institute of Emory University

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

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde

location_facility: Texas Tech University Health Sciences Center; Department of Internal Medicine

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: National Cancer Centre; Medical Oncology

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Azienda Ospedaliera Univ di Udine; Oncologia Medica

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Kyungpook National University Medical Center

location_facility: Townsville Hospital; Haematology and Oncology

location_facility: Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Churchill Hospital; Department of Oncology

location_facility: Maryland Oncology Hematology; Maryland Oncology Hematology, Silver Spring

location_facility: Centrum Onkologii im. Prof. Franciszka Łukaszczyka; Ambulatorium Chemioterapii

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Soon Chun Hyang University Cheonan Hospital

location_facility: Wake Forest University Baptist Medical Center

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

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

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen

location_facility: Wojskowy Instytut Medyczny; Klinika Onkologii

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: London Regional Cancer Program, London Health Sciences Centre, Baines Centre

location_facility: Azienda Ospedaliero Universitaria Pisana; Unita Operativa Oncologia Medica 2

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

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

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Austin Health; Cancer Clinical Trial Centre

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: Harbin Medical University Cancer Hospital

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Helios Klinikum Krefeld; Zentrum für ambulante gynäkologische Onkologie (ZAGO)

location_facility: Waikato Hospital; Dept of Medical Oncology

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

location_facility: Universitätsklinikum St. Pölten; Klinische Abteilung für Innere Medizin 1

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: St Georges University Hospitals NHS Foundation Trust

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

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

location_facility: Royal Marsden Hosp NHS Fnd; Medicine - Breast Unit

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Memorial Healthcare System - Memorial Regional Hospital

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

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

location_facility: Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Fujian Medical University Union Hospital

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

location_facility: SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU; Purulent Surgery department

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

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

location_facility: Barts Health NHS Trust; Cancer Research Delivery Group

location_facility: The Center for Cancer and Blood Disorders - Fort Worth

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GDC-0077 Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in patients with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.

lead_sponsor_type: industriel

status_simplified: Ongoing


design_allocation: Non-Randomized

lead_sponsor: Taiho Oncology, Inc.

location_country:
Italy
United States
Sweden
Hong Kong
Netherlands
Spain
France
Japan
Singapore
Belgium
Portugal
Turkey
Germany
United Kingdom
Korea, Republic of

location_facility: Karolinska universitetssjukhuset - Solna

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Mercy Clinic Oncology and Hematology - Coletta

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

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

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: The University of Texas M. D. Anderson Cancer Center

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio

location_facility: Hospital Clinico Universitario de Valencia

ipd_sharing: No

title: A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations

summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.


intervention_type: Other

status: Active, not recruiting

ipd_sharing_description:
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

enrollment_type: Actual

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
France
Japan
Poland
Slovakia
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Spain

acronym: PACIFIC-STROKE

location_facility: Fondazione Istituto Neurologico Nazionale Casimiro Mondino

location_facility: Univ.of South Florida College of Medicine

location_facility: Regional Clinical Hospital #1 n.a. prof. S.V. Ochapovsky

location_facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice

location_facility: Mazowiecki Szpital Specjalistyczny im. dr. Jozefa Psarskiego

location_facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

location_facility: Fakultna nemocnica s poliklinikou Skalica, a.s.

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Vseobecna nemocnica s poliklinikou Levoca, a.s.

location_facility: First Multiprofile Hospital for Active Treatment Sofia EAD

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatm

location_facility: Gornoslaskie CM im. Prof. Leszka Gieca SUM w Katowicach

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto

location_facility: Railway clinical hospital on the station Novosibirsk-Glavniy

location_facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

location_facility: Svet zdravia, a.s. Nemocnica s poliklinikou Spisska Nova Ves

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Svet zdravia, a.s. Vseobecna nemocnica v Ziari nad Hronom

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Centre Hospitalier Universitaire - Le Kremlin Bicêtre

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Turun yliopistollinen keskussairaala, kantasairaala

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: Svet zdravia, a. s. Vseobecna nemocnica Rimavska Sobota

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Clínico Universitario San Carlos

location_facility: AUSL di Bologna - IRCCS Istituto Scienze Neurologiche

location_facility: Eastern Clinical Research Unit - Box Hill

location_facility: Dolnooravska nemocnica s poliklinikou L. Nadasi Jegeho

location_facility: Sci-Res. Institute of Complex Cardiovascular Disorders

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: University of Pittsburgh Medical Center Hamot

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Universitätsklinikum der Johann Wolfgang Goethe Universität

location_facility: CHUC - Hospitais da Universidade de Coimbra

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni

location_facility: Krankenhaus der Barmherzigen Brüder Eisenstadt

location_facility: Clinical Inter-District Hospital of Vsevolozhsk

location_facility: Klinik Favoriten - Sozialmedizinisches Zentrum Süd

ipd_sharing: Undecided

title: Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke

summary: The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.


ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform(www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
France
Australia
Spain
United States

acronym: CRISTALLO

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Hopital Saint Jean : Pole Santé du Rousillon; Unité de Recherche clinique

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

location_facility: Asl Le-Ospedale "Vito Fazzi";U.O. Ematologia

location_facility: Consultants in Medical Oncology and Hematology, P.C.

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: Royal North Shore Hospital; Haematology Department

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol

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

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Medical Center of Aurora; Rocky Mountain Cancer Centers

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Oncology & Hematolgy Associates of SW Va Inc. - Roanoke

location_facility: Hospital de Navarra, Servicio de Hematología

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Peter MacCallum Cancer Centre; Department of Haematology

location_facility: CHU de Caen, Institut d'Hématologie de Basse-Normandie

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Hopital Robert Debre; Hematologie Clinique

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología

location_facility: Hospital Universitario de Canarias;servicio de Hematologia

location_facility: Canberra Hospital; Haematology Department

title: A Prospective, Open-Label, Multicenter Randomized Phase III Study to Compare The Efficacy and Safety of A Combined Regimen of Venetoclax and Obinutuzumab Versus Fludarabine, Cyclophosphamide, and Rituximab (FCR)/Bendamustine and Rituximab (BR) in FIT Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without DEL(17P) or TP53 Mutation

summary: This study will evaluate the efficacy and safety of venetoclax and obinutuzumab (VEN + G) compared with fludarabine + cyclophosphamide + rituximab or bendamustine + rituximab (FCR/BR) in FIT participants (FIT is defined by a cumulative illness rating scale [CIRS]/score of ≤6 and a normal creatinine clearance of ≥70 mL/min) with previously untreated CLL without DEL(17P) or TP53 mutation requiring treatment. Eligible participants will be randomly assigned in a 1:1 ratio to receive either VEN + G (Arm A) or FCR/BR (Arm B).


ReferenceType: derived

ReferenceCitation: Barry PJ, Mall MA, Álvarez A, Colombo C, de Winter-de Groot KM, Fajac I, McBennett KA, McKone EF, Ramsey BW, Sutharsan S, Taylor-Cousar JL, Tullis E, Ahluwalia N, Jun LS, Moskowitz SM, Prieto-Centurion V, Tian S, Waltz D, Xuan F, Zhang Y, Rowe SM, Polineni D; VX18-445-104 Study Group. Triple Therapy for Cystic Fibrosis Phe508del-Gating and -Residual Function Genotypes. N Engl J Med. 2021 Aug 26;385(9):815-825. doi: 10.1056/NEJMoa2100665.

name: From Manchester University NHS Foundation Trust, Manchester, United Kingdom (P.J.B.); Charité–Universitätsmedizin Berlin, the Berlin Institute of Health, and the German Center for Lung Research, Berlin (M.A.M.), and the Division of Cystic Fibrosis, Department of Pulmonary Medicine, University Medicine Essen–Ruhrlandklinik, University of Duisburg–Essen, Essen (S.S.) — all in Germany; Vall d’Hebron Barcelona Hospital Campus, Barcelona (A.A.); Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico and...

family: Barry

full_name: Peter J. Barry

given: Peter J.

sequence: first

family: Mall

full_name: Marcus A. Mall

given: Marcus A.

sequence: additional

family: Álvarez

full_name: Antonio Álvarez

given: Antonio

family: Colombo

full_name: Carla Colombo

given: Carla

family: de Winter-de Groot

full_name: Karin M. de Winter-de Groot

given: Karin M.

family: Fajac

full_name: Isabelle Fajac

given: Isabelle

family: McBennett

full_name: Kimberly A. McBennett

given: Kimberly A.

family: McKone

full_name: Edward F. McKone

given: Edward F.

family: Ramsey

full_name: Bonnie W. Ramsey

given: Bonnie W.

family: Sutharsan

full_name: Sivagurunathan Sutharsan

given: Sivagurunathan

family: Taylor-Cousar

full_name: Jennifer L. Taylor-Cousar

given: Jennifer L.

family: Tullis

full_name: Elizabeth Tullis

given: Elizabeth

family: Ahluwalia

full_name: Neil Ahluwalia

given: Neil

family: Jun

full_name: Lucy S. Jun

given: Lucy S.

family: Moskowitz

full_name: Samuel M. Moskowitz

given: Samuel M.

family: Prieto-Centurion

full_name: Valentin Prieto-Centurion

given: Valentin

family: Tian

full_name: Simon Tian

given: Simon

family: Waltz

full_name: David Waltz

given: David

family: Xuan

full_name: Fengjuan Xuan

given: Fengjuan

family: Zhang

full_name: Yaohua Zhang

given: Yaohua

family: Rowe

full_name: Steven M. Rowe

given: Steven M.

family: Polineni

full_name: Deepika Polineni

given: Deepika

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Triple Therapy for Cystic Fibrosis Phe508del–Gating and –Residual Function Genotypes

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent research/clinical-trial-data-sharing

location_country:
Italy
United States
Netherlands
Germany
France
Israel
Ireland
Belgium
Australia
Spain
Denmark
Canada
United Kingdom

location_facility: Hospital Universitari Vall d´Hebron Servicio de Broncoscopia

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: The University of Texas Southwestern Medical Center

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie

location_facility: University of Oklahoma Health Sciences Center

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: Charite Paediatric Pulmonology Department

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Northwell Health- Long Island Jewish Medical Center

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: University of California Davis Medical Center

location_facility: Malattie Apparato Respiratorio 2 - Fibrosi Cistica

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: Justus-Liebig-Universitaet Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Banner University of Arizona Medical Center

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

location_facility: University of California San Francisco, Lung Transplant Program

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: The University of Iowa Hospitals and Clinics

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center

location_facility: Azienda Ospedaliera di Verona-Ospedale Civile Maggiore

location_facility: Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital

location_facility: University of Miami Miller School of Medicine

location_facility: Papworth Hospital NHS Foundation Trust, Papworth Everard

location_facility: Washington University School of Medicine / St. Louis Children's Hospital

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: University of Utah / Primary Children's Medical Center

title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

summary: This study will evaluate the efficacy, safety and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a gating or residual function mutation (F/G and F/RF genotypes).


title: A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Rozibafusp Alfa (AMG 570) in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

summary: The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with systemic lupus erythematosus (SLE) have ongoing disease activity despite treatment with standard of care therapies.

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

family: McCourt

full_name: Collette McCourt

given: Collette

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

family: Lima

full_name: Hermenio C Lima

given: Hermenio C

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

family: Chen

full_name: Suephy Chen

given: Suephy

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

family: Bennett

full_name: Cathy Bennett

given: Cathy

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

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

lead_sponsor: Amgen

location_country:
Italy
United States
Hong Kong
Mexico
Spain
Germany
France
Bulgaria
Czechia
Greece
Japan
Poland
Hungary
Argentina
Australia
Russian Federation
Portugal
Canada
Korea, Republic of

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hopital Francois Mitterrand

location_facility: CER San Juan - Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: National Hospital Organization Chibahigashi National Hospital

location_facility: Multiprofile Hospital for Active Treatment Trimontium OOD

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: The Oklahoma Center for Arthritis Therapy and Research Inc

location_facility: Groupe de recherche en maladies osseuses Incorporated

location_facility: Centro Peninsular de Investigación Clínica

location_facility: Articularis Healthcare Group Inc dba Low Country Rheumatology

location_facility: Medical Centre Synexus Sofia EOOD - Branch Stara Zagora

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Tomed Tomasz Miszalski-Jamka Centrum Medyczne

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Trinity Universal Research Associates, Inc

location_facility: Southwest Florida Clinical Research Center

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Centre Hospitalier Universitaire de Strasbourg - Nouvel hopital civil

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Pellegrin

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Penn State Milton South Hershey Medical Center

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

location_facility: Hospital of the University of Occupational and Environmental Health

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: 1 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Centro de Investigacion en Artritis y Osteoporosis SC

location_facility: Feinstein Institute for Medical Research

location_facility: Southern California Permanente Medical Group

location_facility: National University Corporation Tohoku University Tohoku University Hospital

location_facility: University Multiprofile Hospital for Active Treatment - Kaspela EOOD

location_facility: Shared Health Inc. operating the Health Sciences Centre Winnipeg

location_facility: Clinical Mayo - Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Arthritis and Rheumatology Center of Oklahoma PLLC

location_facility: University of Calgary Cumming School of Medicine

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1

location_facility: Rheumatic Disease Clinical Research Center LLC

location_facility: Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz

location_facility: Centre for Rheumatology Immunology and Arthritis

location_facility: University of Maryland School of Medicine Division of Rheumatology

location_facility: Limited liability company Scientific Research Medical Complex Your Health

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Morales Vargas Centro de Investigacion SC

location_facility: Centro Hospitalar do Porto EPE - Hospital de Santo Antonio

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa

location_facility: FSBSI SRI of Rheumatology na V A Nasonova

location_facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de Nacre

location_facility: Instituto Medico de Alta Complejidad San Isidro

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

location_facility: Clinic of Robert Hozman, MD - Clinical Investigational Specialists, Inc

location_facility: Hospital Militar Central - Cirujano Mayor Dr Cosme Argerich

location_facility: Centro Hospitalar Universtario de Sao Joao, EPE

location_facility: New York University Langone Orthopedic Center

location_facility: Fundacion Respirar - Centro Medico Dra De Salvo


title: An Observational Retrospective Cohort Study of Lenalidomide Monotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) to Generate a Historical Control for Clinical Trial MOR208C203 (RE-MIND)

acronym: RE-MIND

summary: This observational study is designed to characterise the effectiveness of lenalidomide monotherapy in the treatment of R/R DLBCL and to compare the results with the efficacy outcomes of a tafasitamab-lenalidomide combination therapy in the clinical trial MOR208C203 (L-MIND)

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

lead_sponsor: MorphoSys AG

location_country:
Italy
United States
France
Spain

location_facility:
MorphoSys Research State
MorphoSys Research Site

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

acronym: CheckMate 7G8

summary: A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

lead_sponsor: Bristol-Myers Squibb

location_country:
Greece
Romania
Australia
Russian Federation
France
Japan
Argentina
Canada
Chile
Sweden
Netherlands
Singapore
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: ICANS-Institut de cancerologie Strasbourg Europe

location_facility: University General Hospital of Athens Attikon


status: Terminated

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

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

lead_sponsor: Celgene

location_country:
United States
Germany
France
Japan
Poland
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Beaujon

location_facility: University of Mississippi Medical Center

location_facility: WestGlen Gastrointestinal Consultants, P.A.

location_facility: North Tees (DRS) Synexus North Teesside Clinical Research Centre

location_facility: University of Calgary, Cumming School of Medicine

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Virginia Commonwealth University School of Medicine

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Digestive Health Associates of Texas (DHAT)

location_facility: Saint Louis University School of Medicine

location_facility: University of Pittsburgh Medical Center - Center for Liver Diseases

location_facility: University of Vermont Medical Center Gastro

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Ohio State University Wexner Medical Center

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)

location_facility: University of Sydney - Royal Prince Alfred Hospital

location_facility: Baylor College of Medicine - Baylor Heart Clinic

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Cochin

location_facility: University of California Davis Medical Center

location_facility: Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego

location_facility: Toronto Center for Liver Disease - Francis Family Liver Clinic

location_facility: Synexus Hexham Clinical Research Centre, Hexham (DRS)

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego

location_facility: Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: Carolinas HealthCare System Digestive Health

location_facility: University of Miami Schiff Center for Liver Diseases

location_facility: Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: The Institute for Digestive Health & Liver Disease at Mercy Medical Center

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou

location_facility: University of Washington Harborview Medical Center

location_facility: University of Colorado, School of Medicine - Hepatology Clinic - Anschutz

location_facility: Tulane University Health Sciences Center

location_facility: Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi

location_facility: University Hospital of Girona Dr. Josep Trueta

location_facility: University of Birmingham Institute of Biomedical Research

type: Other Identifier

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

summary:
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.

This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

status_simplified: Unknown


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

acronym: COURSE

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

lead_sponsor: AstraZeneca

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


title: A Phase III, Randomized, Multicenter, Open-label, Non-inferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir/Lamivudine Fixed Dose Combination in HIV-1 Infected Adults Who Are Virologically Suppressed

summary: The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to dolutegravir/lamivudine (DTG/3TC) fixed dose combination (FDC). The main objective of the study is to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks in virologically suppressed adults living with HIV-1. The study will also evaluate information regarding the safety and health related quality of life. The study will include Screening Phase (up to 28 days), a Randomization Phase (up to Week 52) and a Continuation Phase (post Week 52). The Continuation Phase is not applicable for participants in Sweden and Denmark. Approximately 490 participants will be randomized in 1:1 ratio to receive DTG/3TC FDC once daily for up to 52 weeks or continue their CAR for 52 weeks. Participants in the DTG/3TC FDC arm who successfully complete up to 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in Continuation Phase.

ReferenceCitation: Masters MC, Cohn SE. Two-drug HIV regimens: more data still needed. Lancet HIV. 2021 Aug;8(8):e454-e455. doi: 10.1016/S2352-3018(21)00106-5.

family: Masters

full_name: Mary Clare Masters

given: Mary Clare

family: Cohn

full_name: Susan Ellen Cohn

given: Susan Ellen

journal_name: The Lancet HIV

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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

lead_sponsor: ViiV Healthcare

location_country:
Italy
United States
Brazil
South Africa
Sweden
Mexico
Spain
Germany
France
Belgium
Argentina
Russian Federation
China
Denmark
Canada
United Kingdom
Taiwan


ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Italy
Brazil
United States
Hong Kong
Spain
Germany
France
Czechia
Japan
Malaysia
Poland
Thailand
Belgium
Russian Federation
China
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

location_facility: Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis

location_facility: University of Alberta - Faculty of Medicine & Dentistry

location_facility: Severance Hospital, Yonsei University Health System

location_facility: NHS Greater Glasgow and Clyde - Gartnavel General Hospital

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

location_facility: Hospital das Clinicas da Universidade Federal da Bahia

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Vancouver ID Research and Care Centre Society

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Washington University School of Medicine

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Fundação De Medicina Tropical Doutor Heitor Vieira Dourado

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

location_facility: Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital

location_facility: Tokyo Medical and Dental University Medical Hospital

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin

title: A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

summary: The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.


type: Registry Identifier

title: A Phase 3, Multicenter, Randomized, Open-label Trial to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Docetaxel in Previously Treated Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) and Progressive Disease (PD) After Platinum Doublet Chemotherapy and Immunotherapy (LEAP-008)

summary: This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).

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

name: Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, OR 97213, USA

family: Taylor

full_name: Matthew H Taylor

given: Matthew H

name: Department of Clinical Oncology, Merck & Co. Inc., Kenilworth, NJ 07033, USA

family: Schmidt

full_name: Emmett V Schmidt

given: Emmett V

name: Department of Clinical Research, Eisai Inc., Woodcliff Lake, NJ 07677, USA

family: Dutcus

full_name: Corina Dutcus

given: Corina

family: Pinheiro

full_name: Elaine M Pinheiro

given: Elaine M

name: Biomarker Research Translational Science Department, Eisai Co., Ltd., Tokyo, 112-0002, Japan

family: Funahashi

full_name: Yasuhiro Funahashi

given: Yasuhiro

family: Lubiniecki

full_name: Gregory Lubiniecki

given: Gregory

name: The START Center for Cancer Care, San Antonio, TX 78229, USA

family: Rasco

full_name: Drew Rasco

given: Drew

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Spain
Germany
France
Japan
Greece
Israel
Hungary
Argentina
Australia
Puerto Rico
Portugal
Russian Federation
Canada
United Kingdom
Korea, Republic of
Colombia

location_facility: Kanagawa Cardiovascular and Respiratory Center ( Site 0105)

location_facility: Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0905)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0503)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 0607)

location_facility: Hospital Universitari Vall d Hebron ( Site 1004)

location_facility: Ospedale San Gerardo - ASST Monza ( Site 0804)

location_facility: Niigata Cancer Center Hospital ( Site 0101)

location_facility: GBUZ Republican Clinical Oncological Dispensary ( Site 0922)

location_facility: Hull & East Yorkshire NHS Trust. Castle Hill Hospital ( Site 1108)

location_facility: Hospital Universitario Puerta de Hierro ( Site 1007)

location_facility: Pavlov First Saint Petersburg State Medical University ( Site 0917)

location_facility: Shaare Zedek Medical Center-Oncology ( Site 0706)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 1011)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0918)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 1005)

location_facility: Medstar Good Samaritan Hospital ( Site 1625)

location_facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 1666)

location_facility: Central Clinical Hospital of the Administration of the President ( Site 0910)

location_facility: Tudogyogyintezet Torokbalint ( Site 0602)

location_facility: Birmingham Heartlands Hospital ( Site 1103)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1304)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0808)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 1626)

location_facility: Instituto de Investigaciones Metabolicas ( Site 2004)

location_facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 1644)

location_facility: Princess Alexandra Hospital - Division of Cancer Services ( Site 0002)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0603)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1003)

location_facility: Hospital Britanico de Buenos Aires ( Site 2002)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 0901)

location_facility: AOU Policlinico Vittorio Emanuele ( Site 0811)

location_facility: North Middlesex University Hospital NHS Trust ( Site 1109)

location_facility: Port Macquarie Base Hospital ( Site 0003)

location_facility: Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 1604)

location_facility: Princess Margaret Cancer Centre ( Site 1502)

location_facility: Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 1801)

location_facility: Evangelisches Krankenhaus Hamm gGmbH ( Site 0504)

location_facility: Azienda Ospedaliera San Giuseppe Moscati ( Site 0809)

location_facility: Hospital Universitario 12 de Octubre ( Site 1006)

location_facility: Memorial Sloan-Kettering Cancer Center ( Site 1661)

location_facility: CHU Caen Service de Pneumologie ( Site 0401)

location_facility: General Hospital of Chest Diseases "Sotiria" ( Site 1703)

location_facility: Memorial Sloan-Kettering Cancer Center at Montvale ( Site 1667)

location_facility: Kansai Medical University Hospital ( Site 0104)

location_facility: Severance Hospital Yonsei University Health System ( Site 0202)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 1621)

location_facility: New York Cancer and Blood Specialists ( Site 1696)

location_facility: Kingston Health Sciences Centre ( Site 1503)

location_facility: Thompson Cancer Survival Center ( Site 1695)

location_facility: Puerto Rico Medical Research Center LLC ( Site 2101)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0609)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0501)

location_facility: Seoul National University Bundang Hospital ( Site 0204)

location_facility: Guy s and St Thomas Hospital NHS Foundation Trust ( Site 1102)

location_facility: Southern Medical Day Care Centre ( Site 0001)

location_facility: A.O. Ospedali Riuniti Villa Sofia - Cervello P.O. Villa Sofia ( Site 0810)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0100)

location_facility: Sourasky Medical Center (Ichilov) - Oncology Clinic ( Site 0705)

location_facility: Hospital Clinico de Valencia ( Site 1010)

location_facility: National Cancer Center Hospital ( Site 0103)

location_facility: University of Massachusetts Medical School ( Site 1693)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0610)

location_facility: Ad-Vance Medical Research LLC ( Site 2103)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 1670)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 0608)

location_facility: Centre Hospitalier General - Avignon ( Site 0407)

location_facility: Budgetary Healthcare Institution of Omsk Region Clinical Oncology Dispensary-Chemotherapy #1 ( Site

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0606)

location_facility: Istituto Nazionale dei Tumori ( Site 0806)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 1112)

location_facility: MGH - North Shore Cancer Center ( Site 1668)

location_facility: Chungbuk National University Hospital ( Site 0201)

location_facility: Metropolitan Hospital-4th Oncology Dept ( Site 1700)

location_facility: Memorial Sloan-Kettering Cancer Center at Middletown ( Site 1665)

location_facility: Hematology and Oncology Institute ( Site 2105)

location_facility: St James s University Hospital ( Site 1106)

location_facility: Hospital Universitario Quiron Madrid ( Site 1012)

location_facility: Massachusetts General Hospital ( Site 1622)

location_facility: University Hospital of Ioannina ( Site 1701)

location_facility: Calvary Central Districts Hospital ( Site 0007)

location_facility: Consorci Hospitalari Mataro ( Site 1008)

location_facility: European Interbalkan Medical Center ( Site 1704)

location_facility: Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 0807)

location_facility: Nottingham City Hospital Campus ( Site 1105)

location_facility: London Regional Cancer Program - London HSC ( Site 1505)

location_facility: Cancer Specialists of North Florida - Fleming Island ( Site 1675)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 1501)

location_facility: Administradora Country SA - Clinica del Country ( Site 1307)

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz ( Site 0601)

location_facility: Azienda Ospedaliera di Perugia ( Site 0805)

location_facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1664)

location_facility: Bozeman Health Deaconness Cancer Center ( Site 1632)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 1514)

location_facility: Hospital Central de Asturias ( Site 1002)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 1301)

location_facility: Policlinico San Matteo - Fondazione IRCCS ( Site 0812)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1305)

location_facility: The Mass General Cancer Center at Newton-Wellesley ( Site 1692)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0903)

location_facility: Hopital Europeen Georges Pompidou ( Site 0408)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1662)


title: A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study, Comparing GSK3196165 With Placebo and With Tofacitinib in Combination With Conventional Synthetic DMARDs, in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Conventional Synthetic DMARDs or Biologic DMARDs

acronym: contRAst 2

summary: This study [contRAst 2 (201791: NCT03970837)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165 in combination with csDMARD(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to csDMARD(s) or bDMARD(s). The study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csDMARD(s). Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165 may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

lead_sponsor: GlaxoSmithKline

location_country:
Brazil
Mexico
Spain
Germany
France
Bulgaria
Japan
Poland
Thailand
Hungary
Argentina
Australia
Russian Federation
China
Estonia
United States
United Kingdom
Korea, Republic of
Colombia


ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Austria
Brazil
India
Switzerland
Mexico
France
Czechia
Japan
Israel
Poland
Hungary
Argentina
Australia
Russian Federation
Spain
Germany
United Kingdom
Taiwan

acronym: BREEZE-AD-PEDS

location_facility: Japan National Hospital Organization Mie Hospital

location_facility: Consultorio Privado de la Dra. Villanueva

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

location_facility: Moscow Scientific and Practical Center of Dermatovenerology and Cosmetology

location_facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: IDERJ - Instituto de Dermatologia e Estética do Brasil

location_facility: Queen's Medical Centre, Nottingham University Hospitals

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Instituto de Neumonología y Dermatología

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Aakash Healthcare Super Speciality Hospital

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Instituto Brasil de Pesquisa Clínica - IBPCLIN

location_facility: State Healthcare Instit Tula Reg Dermatov Dispensary

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

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

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

location_facility: CRI Centro Regiomontano de Investigación

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

location_facility: Post Graduate Institute of Medical Education & Research

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

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

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


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

acronym: TELLOMAK

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

lead_sponsor: Innate Pharma

location_country:
Italy
United States
France
Spain
Germany
United Kingdom

location_facility: Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie

location_facility: Columbia University Pediatric Neuromuscular Center Columbia UMC

location_facility: Washington University School of Medicine

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

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Hôpital Saint-Louis Service de Dermatologie

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: CHRU de Montpellier - Hopital Saint Eloi

location_facility: University of Pittsburgh School of Medicine

location_facility: Institut Claudius Regaud Département de Dermatologie

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

location_facility: Consorci Hospital General Universitari de Valencia Servicio de Dermatología

location_facility: CHRU de Tours, Hôpital Trousseau, service Dermatologie

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

location_facility: Istituto di Ematologia Lorenzo e Ariosto Seragnoli

intervention_type: Biological


title: A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

acronym: IXchange

summary: The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with GPA and MPA.

lead_sponsor: InflaRx GmbH

location_country:
Italy
Sweden
Switzerland
Netherlands
France
Czechia
Belgium
Russian Federation
Spain
Germany
United Kingdom

location_facility:
Clinical Site
Clinical site


title: A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

summary: An observational study to evaluate the natural progression of dry AMD in genetically defined subjects

time_perspective: Prospective

lead_sponsor: Gyroscope Therapeutics Limited

location_country:
United States
Netherlands
France
Poland
Australia
Spain
Germany
United Kingdom

location_facility: Oftalmika - Prywatna Klinika Okulistyczna

location_facility: Hospital General de Catalunya Sant Cugat del Valles

location_facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu

location_facility: Specjalistyczny Osrodek Okulistyczny Oculomedica

location_facility: University Hospital Schleswig-Holstein - Campus Luebeck

location_facility: Retinal Research Institute (retina consultants of AZ)

location_facility: Retina Vitreous Associates Medical Group

location_facility: Johns Hopkins University School of Medicine

location_facility: The University of Melbourne - The Centre for Eye Research Australia (CERA)

location_facility: Klinika Okulistyczna Jasne Blonia Sp. z o.o.


title: An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

summary:
Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:

In patients with follicular lymphoma (FL) grade 1-3a *1,2
In patients with diffuse large B-cell lymphoma (DLBCL) *1,2
In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.
In patients with marginal zone lymphoma (MZL) *1
In patients with other B-NHL subtypes *1

Secondary objectives are:

To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:
ORR according to the Lugano Classification and as assessed by local investigator evaluation
Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review
Progression-free survival (PFS)*3
Overall survival (OS)
Duration of response (DOR)*3
Disease control rate (DCR)*3
To evaluate the safety and tolerability of odronextamab
To assess the pharmacokinetics (PK) of odronextamab
To assess the immunogenicity of odronextamab

To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)

1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
2 including an anti-CD20 antibody and an alkylating agent
3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

ipd_sharing_description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Italy
United States
Spain
Germany
France
Poland
Singapore
Australia
China
Canada
United Kingdom
Korea, Republic of
Taiwan


title: Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-label, Active-controlled, Multicenter Trial

acronym: EMERALD

summary: This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

ReferenceCitation: Bardia A, Aftimos P, Bihani T, Anderson-Villaluz AT, Jung J, Conlan MG, Kaklamani VG. EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. Future Oncol. 2019 Oct;15(28):3209-3218. doi: 10.2217/fon-2019-0370. Epub 2019 Aug 20.

name: Massachusetts General Hospital Cancer Center, Departments of Medicine and Hematology/Oncology, 55 Fruit Street Boston, MA 02114-3411, USA

family: Bardia

full_name: Aditya Bardia

given: Aditya

name: Clinical Trials Conduct Unit, Institut Jules Bordet, Université Libre de Bruxelles, Rue Heger-Bordet1, 1000 Brussels, Belgium

family: Aftimos

full_name: Philippe Aftimos

given: Philippe

name: Radius Health, Inc., 950 Winter Street Waltham, MA 02451, USA

family: Bihani

full_name: Teeru Bihani

given: Teeru

family: Anderson-Villaluz

full_name: Alfred T Anderson-Villaluz

given: Alfred T

family: Jung

full_name: JungAh Jung

given: JungAh

family: Conlan

full_name: Maureen G Conlan

given: Maureen G

name: UT Health San Antonio MD Anderson Cancer Center, Division of Hematology/Oncology 7979 Wurzbach Road, San Antonio, TX 78229, USA

family: Kaklamani

full_name: Virginia G Kaklamani

given: Virginia G

lead_sponsor: Radius Pharmaceuticals, Inc.

location_country:
Italy
Austria
Spain
France
Korea, Republic of
Greece
Israel
Hungary
Argentina
Australia
Belgium
Ireland
Denmark
United States
United Kingdom
Canada
Portugal

location_facility: Cliniques Universitaires Saint-Luc - Oncology

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna - SSD Oncol.Med. Addarii-Zamagni

location_facility: New Mexico Oncology Hematology Consultants - Oncology

location_facility: Pikeville Medical Center - Oncology/Hematology

location_facility: Azienda Ospedaliero-Universitaria di Parma

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

location_facility: Universitaire Ziekenhuizen (UZ) - Leuven Cancer Institute

location_facility: US Oncology Research-- Investigational Product Center

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: CHU de Quebec - Hopital du Saint Sacrement

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Hopital Trousseau - Service d'oncologie mÃ©dicale

location_facility: Cancer Therapy and Research Center at UTHSCSA

location_facility: Chicago Association for Research and Education in Science

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: Institut Jules Bordet - Oncologie Médicale

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: US Oncology - Rocky Mountain Cancer Centers - Midtown

location_facility: DiMI, Dipartimento di Medicina interna e Specialità mediche,

location_facility: Severance Hospital, Yonsei University Health System

location_facility: INDC Entité Jolimontoise - CH de Jolimont-Lobbes

location_facility: University General Hospital Of Patras - Dpt Of Medicine, Division Oncology

location_facility: McGill University Health Centre - Cedars Cancer Center - Oncology

location_facility: Instituto Português de Oncologia de Coimbra

location_facility: "Institut de Cancérologie Lucien Neuwirth Service pharmacie-Essais cliniques"

location_facility: Hospital Senhora da Oliveira - Guimarães, E.P.E.

location_facility: Centre François Baclesse Service Pharmacie

location_facility: "Institut régional du Cancer Montpellier Service pharmacie-Essais cliniques"

location_facility: Policlinico Universitario Campus Bio-medico, Università Campus Bio-medico di Roma,

location_facility: Mass General Cancer Center at Newton Wellesley - Oncology

location_facility: PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona

location_facility: Clinical Research Facility, St. James's Hospital

location_facility: Piedmont Cancer Institute, P.C. - Oncology

location_facility: Keck Hospital of USC-Norris Healthcare (HC3), Investigational Drug Service (IDS)

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: Brig Center For Cancer Care And Survivorship

location_facility: Rabin Medical Center - Beilinson Hospital - Davidoff Cancer

location_facility: UC Davis Medical Center, Investigational Drug Service

location_facility: Seoul National University Bundang Hospital

location_facility: Hôpital Privé Jean Mermoz Département Pharmacie

location_facility: Poudre Valley Health Care, Inc. d/b/a Poudre Valley Health System

location_facility: Pharmacy Aseptic Compounding Unit Level 4, Sligo University Hospital

location_facility: Benaroya Research Institute at Virginia Mason

location_facility: Centre De Lutte Contre Le Cancer - Institut Curie - DÃ©partement d'Oncologie MÃ©dica

location_facility: New York University Clinical Cancer Center

location_facility: AOU Maggiore della Carità - SC Oncologia

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Saint Barnabas Medical Center - Cancer Center

location_facility: Hôpital René Huguenin - Institut Curie - Oncologie médicale

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: Texas Oncology - Central Austin Cancer Center

location_facility: Mass General North Shore Cancer Center - Oncology

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: Fundacion CENIT para la Investigación en Neurociencias - Clinic

location_facility: Centre Hospitalier de l'Ardenne - Site de Libramont


ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
Brazil
United States
Netherlands
Germany
France
Czechia
Japan
Israel
Poland
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: PROTEUS

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: San Raffaele Turro - Istituto di Ricovero e Cura a Carattere Scientifico

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

location_facility: Emory University - Winship Cancer Institute

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Samodzielny Publiczny Wielospecjalistyczny Zakład Opieki Zdrowotnej MSWiA w Bydgoszczy

location_facility: UOC di Urologia AOU Integrata di Verona - Polo Chirurgico Confortini - Ospedale Borgo Trento

location_facility: Mayo Clinic - Division Of Hematology/oncology

location_facility: Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

location_facility: Kliniken Nordoberpfalz, Klinik für Urologie

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Vancouver Prostate Centre, Gordon and Leslie Diamond Health Care Centre

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Fakultni nemocnice Plzen, Urologicka klinika

location_facility: ICESP - INSTITUTO DO CANCER DO ESTADO DE SAO PAULO OCTAVIO FRIAS de OLIVEIRA

location_facility: CHUM - Centre hospitalier universitaire de Montreal

location_facility: Praxisgemeinschaft f. Onkologie u. Urologie - Germany

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: CAMC Memorial Hospital, Charleston Area Medical Center Physicians

location_facility: Great Lakes Physician PC d/b/a Western New York Urology Associates

location_facility: Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust Royal Preston Hospital

location_facility: Martini-Klinik am Universitätsklinikum Hamburg-Eppendorf Urologie

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

location_facility: Seoul National University Bundang Hospital

location_facility: Oklahoma University Health Science Center

location_facility: Tel Aviv University Sackler School of Medicine - Meir Medical Center (MMC)

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

location_facility: National Hospital Organizaiton Shikoku Cancer Center

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie

location_facility: Dolnoslaskie Centrum Onkologii, Oddzial Chirurgii Onkologicznej II - Urologia

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Kobe City Medical Center General Hospital

location_facility: University of Washington School of Medicine

location_facility: ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti

location_facility: Miami Cancer Institute at Baptist Health / Baptist Health Medical Group

location_facility: Clinica di Urologia Policlinico di Modena - Università di Modena e reggio Emilia

location_facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

location_facility: St. Antonius Ziekenhuis (St. Antonius Hospital)

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Hospital Haroldo Juaçaba - Instituto do Câncer do Ceará

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

summary: The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) based on conventional imaging, as compared to placebo plus ADT.