title: A Phase 3, Randomized, Double-Blind Study of BMS-936558 vs Dacarbazine in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

acronym: CheckMate 066

summary: The purpose of this study is to compare the clinical benefit, as measured by overall survival, of nivolumab with that of. dacarbazine in patients with previously untreated, unresectable, or metastatic melanoma

ReferenceCitation: Robert C, Long GV, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Rutkowski P, Hassel JC, McNeil CM, Kalinka EA, Lebbé C, Charles J, Hernberg MM, Savage KJ, Chiarion-Sileni V, Mihalcioiu C, Mauch C, Arance A, Cognetti F, Ny L, Schmidt H, Schadendorf D, Gogas H, Zoco J, Re S, Ascierto PA, Atkinson V. Five-Year Outcomes With Nivolumab in Patients With Wild-Type BRAF Advanced Melanoma. J Clin Oncol. 2020 Nov 20;38(33):3937-3946. doi: 10.1200/JCO.20.00995. Epub 2020 Sep 30.

name: Université Paris-Saclay, Le Kremlin-Bicêtre, France

family: Robert

full_name: Caroline Robert

given: Caroline

name: Melanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, New South Wales, Australia

family: Long

full_name: Georgina V. Long

given: Georgina V.

name: Cabrini Health, Melbourne, Victoria, Australia

family: Brady

full_name: Benjamin Brady

given: Benjamin

name: Hôpital Saint André Centre Hospitalier Universitaire, Bordeaux, France

family: Dutriaux

full_name: Caroline Dutriaux

name: Center for Immuno-Oncology, University Hospital of Siena, Siena, Italy

family: Di Giacomo

full_name: Anna Maria Di Giacomo

given: Anna Maria

name: University of Lille, INSERM U1189, Service de Dermatologie, Chu Lille, Lille, France

family: Mortier

full_name: Laurent Mortier

given: Laurent

name: Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

name: National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Germany

family: Hassel

full_name: Jessica C. Hassel

given: Jessica C.

name: Chris O’Brien Lifehouse, Melanoma Institute Australia, and Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

family: McNeil

full_name: Catriona M. McNeil

given: Catriona M.

name: Polish Mother’s Memorial Hospital-Research Institute, Lodz, Poland

family: Kalinka

full_name: Ewa Anna Kalinka

given: Ewa Anna

name: Université de Paris, INSERM U976, and Dermatology and CIC, AP-HP, Saint Louis Hospital, Paris, France

family: Lebbé

full_name: Céleste Lebbé

given: Céleste

name: Grenoble Alpes University Hospital, INSERM U1209, Grenoble Alpes University, Grenoble, France

family: Charles

full_name: Julie Charles

given: Julie

name: Helsinki University Hospital, Helsinki, Finland

family: Hernberg

full_name: Micaela M. Hernberg

given: Micaela M.

name: British Columbia Cancer Agency, University of British Columbia, Vancouver, British Columbia, Canada

family: Savage

full_name: Kerry J. Savage

given: Kerry J.

name: Oncology Institute of Veneto Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy

family: Chiarion-Sileni

full_name: Vanna Chiarion-Sileni

given: Vanna

name: Royal Victoria Hospital, McGill University, Montreal, Quebec, Canada

family: Mihalcioiu

full_name: Catalin Mihalcioiu

given: Catalin

name: University Hospital Cologne and Centrum für Integrierte Onkologie Köln, Bonn, Germany

family: Mauch

full_name: Cornelia Mauch

given: Cornelia

name: Hospital Clínic Barcelona, Barcelona, Spain

family: Arance

full_name: Ana Arance

given: Ana

family: Cognetti

full_name: Francesco Cognetti

given: Francesco

name: Department of Oncology, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden

family: Ny

full_name: Lars Ny

given: Lars

name: Aarhus University Hospital, Aarhus, Denmark

family: Schmidt

full_name: Henrik Schmidt

given: Henrik

name: Department of Dermatology, Comprehensive Cancer Center, University Hospital Essen, Essen, Germany

name: German Cancer Consortium, Heidelberg, Germany

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

name: National and Kapodistrian University of Athens, Athens, Greece

family: Gogas

full_name: Helen Gogas

name: Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy

name: Princess Alexandra Hospital, Woolloongabba, and Gallipoli Medical Research Foundation, Greenslopes Private Hospital, Greenslopes, Queensland, Australia

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repositories: HELDA - Digital Repository of the University of Helsinki

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Ascierto PA, Long GV, Robert C, Brady B, Dutriaux C, Di Giacomo AM, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbé C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Ny L, Arance A, Svane IM, Schadendorf D, Gogas H, Saci A, Jiang J, Rizzo J, Atkinson V. Survival Outcomes in Patients With Previously Untreated BRAF Wild-Type Advanced Melanoma Treated With Nivolumab Therapy: Three-Year Follow-up of a Randomized Phase 3 Trial. JAMA Oncol. 2019 Feb 1;5(2):187-194. doi: 10.1001/jamaoncol.2018.4514. Erratum in: JAMA Oncol. 2019 Feb 1;5(2):271.

name: Melanoma, Cancer Immunotherapy and Innovative Therapy Unit, Istituto Nazionale Tumori Fondazione Pascale, Naples, Italy

name: Melanoma Institute Australia, Sydney, New South Wales, Australia

name: Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia

name: Department of Medical Oncology, Northern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, New South Wales, Australia

name: Department of Medicine, Institute Gustave Roussy, Villejuif, France

name: Medical Oncology and Haematology, Cabrini Health, Melbourne, Victoria, Australia

name: Dermatology Service, University Hospital of Bordeaux, Bordeaux, France

name: UOC Oncological Immunotherapy, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy

name: Clinique de Dermatologie, Unité d’Onco-Dermatologie, Institut National de la Santé et de la Recherche Médicale (INSERM) U1189, Centre Hospitalier Régional Universitaire de Lille, Lille, France

name: Department of Dermatology, University Hospital Heidelberg and National Center for Tumor Diseases, Heidelberg, Germany

name: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute–Oncology Center, Warsaw, Poland

name: Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

name: Polish Mother’s Memorial Hospital Research Institute, Lodz, Poland

name: Centre for Lymphoid Cancer, BC Cancer Agency, Vancouver, British Columbia, Canada

name: Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland

name: Assistance Publique–Hôpitaux de Paris Dermatology and Centre d’Investigation Clinique, University Paris Diderot INSERM U976, Saint Louis Hospital, Paris, France

name: Institute for Advanced Biosciences, Université Grenoble Alpes/INSERM U1209/CNRS UMR 5309 Joint Research Center, Grenoble, France

name: Dermatology Department, Grenoble Alpes University Hospital, Grenoble, France

name: Department of Oncology, McGill University, Montreal, Quebec, Canada

name: Melanoma Cancer Unit, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy

name: Department of Dermatology, University Hospital Cologne, Cologne, Germany

name: Division of Oncology, Regina Elena Institute, Rome, Italy

name: Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden

name: Hospital Clinic and Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain

name: Center for Cancer Immune Therapy, Herlev Hospital, Herlev, Denmark

name: Department of Oncology, Copenhagen University Hospital, Herlev, Denmark

name: Department of Dermatology, University Hospital Essen, Essen, Germany

name: First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece

name: Global Biometric Sciences, Bristol-Myers Squibb, Princeton, New Jersey

name: Oncology Clinical Development, Bristol-Myers Squibb, Princeton, New Jersey

name: Princess Alexandra Hospital, University of Queensland, Woolloongabba, Queensland, Australia

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Márquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.

name: Melanoma Institute Australia, University of Sydney, Sydney, New South Wales, Australia3Mater Hospital, North Sydney, New South Wales, Australia

name: Department of Medical Oncology, Moffitt Cancer Center, Tampa, Florida5now with Department of Medical Oncology, Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York

name: Department of Oncology, Royal Marsden Hospital, London, United Kingdom

name: Gallipoli Medical Research Foundation and Princess Alexandra Hospital, and University of Queensland, Queensland, Australia

name: Department of Dermatology and Skin Cancer, Hospital Timone APHM, Aix-Marseille University, Marseille, France

name: Department of Skin, University Hospital Essen, Essen, Germany10Department of Urology, University Hospital Essen, Essen, Germany

name: Department of Dermatology, UniversitaetsSpital, Zurich, Switzerland

name: Department of Medicine Institute Gustave Roussy, Gustave Roussy and Paris-Sud University, Villejuif Paris-Sud, France

name: Servicio de Oncología Médica, Hospital General Universitario Gregorio Marañón, Madrid, Spain

name: Chris O’Brien Lifehouse, Melanoma Institute Australia, Camperdown, New South Wales, Australia15Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

name: Department of Oncology, Aarhus University Hospital, Aarhus, Denmark

name: Department of Medical Oncology, Coffs Harbour Health Campus, New South Wales, Australia

name: Melanoma Clinic at King Albert II Cancer Institute, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Bruxelles, Belgium

name: Melanoma Center and Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts

name: Ludwig Center for Cancer Immunotherapy at Memorial Sloan Kettering Cancer Center, New York, New York

ReferenceCitation: Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebbé C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Arance A, Schmidt H, Schadendorf D, Gogas H, Lundgren-Eriksson L, Horak C, Sharkey B, Waxman IM, Atkinson V, Ascierto PA. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015 Jan 22;372(4):320-30. doi: 10.1056/NEJMoa1412082. Epub 2014 Nov 16.

name: The authors' affiliations are listed in the Appendix.

repository_institution: Lund University - Lund University Publications

repositories_institution: Lund University - Lund University Publications

title: Nivolumab in Previously Untreated Melanoma withoutBRAFMutation

location_country: Italy Chile Sweden Mexico Germany Finland France Poland Greece Israel Norway Argentina Australia Spain Denmark Canada

location_facility: Instituto Medico Especialazado Alexander Fleming


design_allocation: Randomized

intervention_type: Drug

status: Recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Taiho Oncology, Inc.

enrollment_type: Anticipated

primary_purpose: Treatment

location_country:
Italy
Austria
Brazil
Germany
France
Poland
Hungary
Belgium
Puerto Rico
Russian Federation
Spain
Denmark
United States
Ukraine

acronym: SUNLIGHT

location_facility: "Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie"

location_facility: "S.C. Oncologia - Responsabile S.S. Sperimentazioni Cliniche ASMN - IRCCS di Reggio Emilia"

location_facility: "Orszagos Onkologiai Intezet ""B"" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O."

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

location_facility: "Scientific Centre for Specialized Medical Care (oncological) Chemotherapy"

location_facility: "Aalborg Universitetshospital, Syd Onkologisk Afdeling"

location_facility: "Odense Universitetshospital Department of Oncology"

location_facility: "Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii"

location_facility: "Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"

location_facility: "Oncologia Medica A.O. Universitaria di Cagliari Policlinico Universitario "Duilio Casula" di Monserrato"

location_facility: "Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly"

location_facility: "SBIH of YR ""Clinical oncology hospital"" chemotherapy department"

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

location_facility: "Unità Operativa Complessa Oncologia Medica 1 Istituto Oncologico Veneto - IRCCS"

location_facility: "H.VIRGEN DEL ROCIO Servicio de Oncología Médica"

location_facility: "Universitair Ziekenhuis Antwerpen Oncologie"

location_facility: "Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology"

location_facility: "H. Valle de Hebrón Servicio de Oncología - (VHIR)"

location_facility: "Moscow City Oncology Hospital # 62 chemotherapy department"

location_facility: "Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"

location_facility: "Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"

location_facility: "Bekes Megyei Kozponti Korhaz Onkologia"

location_facility: "Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy"

location_facility: "CHU de Poitiers Pole Régional de Cancérologie"

location_facility: "SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii"

location_facility: "Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"

location_facility: "National Medical Research Center of Oncology N.N. Petrova "

location_facility: "HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"

location_facility: "Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médica "

location_facility: "Kursk Regional Clinical Oncology Dispensary General Oncology Department"

location_facility: "National Cancer Institute Department of minimally invasive and endoscopic surgery, interventional radiology "

location_facility: "U.O. Oncologia Medica Azienda Ospedaliera Regionale - Potenza Ospedale ""San Carlo"" - Potenza"

location_facility: "Arkhangelsk Clinical Oncology Dispensary chemotherapy department"

location_facility: "JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum"

location_facility: "Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica"

location_facility: "Saint Petersburg City Oncology Clilnic "

location_facility: "Hospital A C Camargo Unidade de Pesquisa Clinica"

location_facility: "Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej"

location_facility: "MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"

location_facility: "Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet"

location_facility: "Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"

location_facility: "Hospital Albert Einstein Instituto de Ensino e Pesquisa"

location_facility: "Clinical Oncology Dispensary No.1 Chemotherapy Department"

location_facility: "Hôpital Saint-Antoine Service d'Oncologie Médicale"

location_facility: "Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika"

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: "Hospital de la Santa Creu I Sant Pau Oncología Medica"

location_facility: "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"

location_facility: "Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei "

location_facility: "Ordensklinikum Linz Barmherzige Schwestern Interne I"

location_facility: "Centre de lutte contre le cancer Francois Baclesse UCP Digestif"

location_facility: "Onkologische Schwerpunktpraxis Kurfuerstendamm "

location_facility: S.C. di Oncologia Medica Addominale Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"""

location_facility: S.C. di Oncologia Medica Addominale Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: "Dipartimento di Onco-Ematologia Ospedale IRCSS Casa Sollievo della Sofferenza"

location_facility: "Hospital Universitario Marqués de Valdecilla oncología medica"

location_facility: "INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"

location_facility: "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"

location_facility: "LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department"

location_facility: "Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly"

location_facility: "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"

location_facility: "ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"

location_facility: "National Medical Research Centre of Radiology Moscow Research Oncology Institute N.A. Herzen"

location_facility: "Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii"

location_facility: DuPage Medical Group - Joliet Oncology-Hematology Associates

location_facility: "Hospital de Base Centro Integrado de Pesquisa"

location_facility: "Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly"

location_facility: "Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o."

location_facility: "Omsk Clinical Oncologic Dispensary Chemotherapy"

location_facility: "Oncology dispensary No.2 Oncology department"

location_facility: "Wojskowy Instytut Medyczny Klinika Onkologii"

location_facility: "Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre"

location_facility: "CHU Morvan Institut de Cancérologie et d'Hématologie"

location_facility: "H. GENERAL DE VALENCIA Servicio de Oncología Médica"

location_facility: "CHU Jean Minjoz Service d'oncologie médicale"

location_facility: "U.O. di Oncologia Medica Polo Oncologico Edificio 22 Stabilimento Santa Chiara AZ. Osped. Universitaria Pisana"

location_facility: "UZ Leuven Campus Gasthuisberg Digestieve Oncologie"

location_facility: Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

location_facility: "Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"

location_facility: "Podillia Regional Oncology Centre Chemotherapy Department"

location_facility: U.O.C. OncoEmatologia Dipartimento di Medicina di Precisione c/o Nuovo Policlinico Università degli studi della Campania "Luigi Vanvitelli"

location_facility: "Unità Operativa di Oncologia ed Ematologia Istituto Clinico Humanitas"

location_facility: "University Headache Clinic Outpatient oncology clinic"

ipd_sharing: No

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)

summary: This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

type: Registry Identifier

title: An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

summary:
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).

The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.

ipd_sharing: Yes

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Guatemala
Finland
Malaysia
Australia
Russian Federation
Denmark
Taiwan
Ukraine
Croatia
France
Poland
Norway
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hungary
Germany
United States
Mexico
Czechia
Spain
Turkey

location_facility: Korea University Anam Hospital ( Site 4206)

location_facility: Seoul National University Hospital ( Site 4201)

location_facility: Cancer Research Center - HealthPartners/Park Nicollet ( Site 0005)

location_facility: Akershus universitetssykehus ( Site 2000)

location_facility: FBHI Privolzhsky District Medical Center of the FMBA ( Site 2611)

location_facility: Hospital Clinico San Carlos ( Site 1503)

location_facility: Sanatorio Nuestra Senora del Pilar ( Site 0702)

location_facility: Centro de Investigacion Clinica de Oaxaca ( Site 0605)

location_facility: Vanderbilt University Medical Center ( Site 0069)

location_facility: Oregon Health & Science University ( Site 0071)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 1203)

location_facility: Taichung Veterans General Hospital ( Site 4403)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0610)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2309)

location_facility: Centro Medico Integral de Cancerologia CEMIC ( Site 0701)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0019)

location_facility: Fundacion Arturo Lopez Perez ( Site 0400)

location_facility: Massachusetts General Hospital ( Site 0094)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 2710)

location_facility: Beth Israel Deaconess Medical Center ( Site 0089)

location_facility: Rush University Medical Center ( Site 0040)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2901)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 2615)

location_facility: Norton Cancer Institute - St. Matthews ( Site 0065)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 2903)

location_facility: Radomskie Centrum Onkologii ( Site 2418)

location_facility: The University of Alabama at Birmingham ( Site 0010)

location_facility: Ankara Universitesi Tip Fakultesi ( Site 2902)

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 2621)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 3009)

location_facility: New England Cancer Specialists ( Site 0082)

location_facility: Fakultni Thomayerova nemocnice ( Site 2201)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 2100)

location_facility: Moscow Oncological Clinical Dispensary #1 ( Site 2619)

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 2202)

location_facility: Universiti Malaya Medical Centre ( Site 4300)

location_facility: Dana Farber Cancer Institute ( Site 0093)

location_facility: Kyiv City Clinical Oncology Center ( Site 2706)

location_facility: Taipei Veterans General Hospital ( Site 4402)

location_facility: Lahey Hospital & Medical Center ( Site 0090)

location_facility: Centro Investigacion Cancer James Lind ( Site 0402)

location_facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 1500)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1504)

location_facility: Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061)

location_facility: Hospital Universitario 12 de Octubre ( Site 1505)

location_facility: Sykehuset Østfold HF Kalnes ( Site 2003)

location_facility: Instituto Nacional de Cancerología E.S.E. ( Site 0503)

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 2406)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2301)

location_facility: Cancercare Rondebosch Oncology ( Site 3005)

location_facility: Norrlands Universitetssjukhus ( Site 2106)

location_facility: Orszagos Onkologiai Intezet ( Site 2304)

location_facility: Lviv State Regional Oncological Center ( Site 2712)

location_facility: Klinički Bolnički Centar Split ( Site 3202)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2405)

location_facility: Clinical oncology dispensary of Dnipro ( Site 2700)

location_facility: Advent Health Hematology & Oncology ( Site 0003)

location_facility: Jasz - Nagykun Szolnok megyei Hetenyi Geza Korhaz - Rendelointezet ( Site 2300)

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi ( Site 2905)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 2704)

location_facility: Roswell Park Cancer Institute ( Site 0032)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0506)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 2715)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1502)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0018)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0704)

location_facility: Kuopion Yliopistollinen Sairaala ( Site 1803)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2904)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2900)

location_facility: Univ. Pretoria and Steve Biko Academic Hospitals ( Site 3002)

location_facility: The Loginov Moscow Clinical Scientific Center ( Site 2604)

location_facility: Administradora Country SA - Clinica del Country ( Site 0504)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)

location_facility: Ivano-Frankivsk Regional Hospital-Urology department ( Site 2707)

location_facility: City clinical oncological dispensary ( Site 2605)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 2906)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2308)

location_facility: UCLA Hematology Oncology Santa Monica ( Site 0048)

location_facility: University Cancer & Blood Center, LLC ( Site 0057)

location_facility: Vaal Triangle Oncology Centre ( Site 3010)

location_facility: Fakultni nemocnice u sv. Anny v Brne ( Site 2205)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1501)

location_facility: Klinicki Bolnicki Centar Zagreb ( Site 3200)

location_facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 2711)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 2407)

location_facility: Soerlandet sykehus HF Kristiansand ( Site 2007)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 2412)

location_facility: Emory University Winship Cancer Institute ( Site 0012)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 2002)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 4405)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 2609)

location_facility: National Cheng Kung University Hospital ( Site 4404)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 2709)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 2001)

location_facility: Chungnam National University Hospital ( Site 4205)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 4302)

location_facility: Oncólogos del Occidente S.A ( Site 0501)

location_facility: Helios Kliniken Schwerin GmbH ( Site 1302)

location_facility: Masarykuv onkologicky ustav ( Site 2203)

location_facility: Severance Hospital Yonsei University Health System ( Site 4204)

location_facility: Regional Oncology Center of Kharkiv ( Site 2708)

location_facility: National Taiwan University Hospital ( Site 4401)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2617)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 2102)

location_facility: Markusovszky Egyetemi Oktatokorhaz ( Site 2303)


title: A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19

acronym: SPRINTER

summary: The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

ipd_sharing: Undecided

lead_sponsor: Synairgen Research Ltd.

location_country:
Italy
Brazil
India
Serbia
Mexico
Netherlands
Germany
Spain
France
Israel
Romania
Belgium
Argentina
Portugal
United States
United Kingdom
Colombia

location_facility: Bangalore Medical College and Research Institute

location_facility: Newcastle University - Institute of Cellular Medicine (ICM)

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: Clínica Sociedad Española de Beneficencia

location_facility: Post Graduate Institute of Medical Education & Research, Chandigarh

location_facility: Sociedade Literaria e Caritativa Santo Agostinho

location_facility: Oriion Citicare Super Speciality Hospital - Intern

location_facility: Fundación Santos y de la Garza Evia, I.B.P


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

location_country:
Italy
France
Japan
Belgium
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Baylor Charles A. Sammons Cancer Center at Dallas

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: AUSL di Bologna - IRCCS Istituto Scienze Neurologiche

location_facility: H. Lee Moffitt Cancer Center & Research Institute

title: A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors

summary:
Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.

The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).

The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.

During the trial, the doctors will take pictures of the participants' tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.


title: A Phase 3, Randomized, Open-label Study to Evaluate Perioperative Enfortumab Vedotin Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Gemcitabine and Cisplatin in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-B15 / EV-304)

summary: The purpose of this study is to assess the antitumor efficacy and safety of perioperative enfortumab vedotin (EV) plus pembrolizumab and radical cystectomy (RC) + pelvic lymph node dissection (PLND) compared with the current standard of care (neoadjuvant chemotherapy [gemcitabine plus cisplatin] and RC + PLND) for participants with MIBC who are cisplatin-eligible. The dual primary hypotheses are preoperative EV + pembrolizumab and RC + PLND (Arm A) will achieve superior pathologic complete response (pCR) rate and perioperative EV and pembrolizumab and RC + PLND (Arm A) will achieve superior event free survival (EFS) compared with neoadjuvant gemcitabine + cisplatin and RC + PLND (Arm B).

location_country:
Italy
United States
South Africa
Spain
Germany
France
Czechia
Greece
Israel
Japan
Malaysia
Poland
Australia
Russian Federation
Portugal
Canada
Korea, Republic of
Ukraine

location_facility: Hospital Clinico Universitario San Carlos de Madrid ( Site 0651)

location_facility: Krankenhaus Martha Maria Halle-Doelau ( Site 0507)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0657)

location_facility: Caritas Krankenhaus St. Josef ( Site 0502)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1055)

location_facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

location_facility: Okayama University Hospital ( Site 1516)

location_facility: Hirosaki University Hospital ( Site 1501)

location_facility: Zhytomyr Regional Oncology Center ( Site 0961)

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval ( Site 0952)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0658)

location_facility: St.Petersburg Clinical Hospital RAS ( Site 0864)

location_facility: Presidio Ospedaliero Santa Maria delle Grazie ( Site 0599)

location_facility: Fakultni nemocnice u sv. Anny v Brne ( Site 0253)

location_facility: Seoul National University Hospital ( Site 1351)

location_facility: University of Louisville, James Graham Brown Cancer Center ( Site 0022)

location_facility: University Malaya Medical Centre ( Site 0352)

location_facility: Hospital Universitario Central de Asturias ( Site 0654)

location_facility: General Hospital of Athens "Alexandra" ( Site 0303)

location_facility: CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0401)

location_facility: Lviv Oncology Regional Treatment and Diagnostic Center ( Site 0960)

location_facility: CHU Limoges Hopital Dupuytren ( Site 0459)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0461)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 0655)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0011)

location_facility: Sverdlovsky Regional Clinical hospital #1 ( Site 0868)

location_facility: Hopital Diaconesses Croix Saint Simon ( Site 0465)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0035)

location_facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0301)

location_facility: Ospedali Riuniti Umberto I GM Lancis G Salesi ( Site 0593)

location_facility: Saint Francis Cancer Center ( Site 0008)

location_facility: Hospital Universitari de Girona Doctor Josep Trueta ( Site 0653)

location_facility: MNPE Regional Center of Oncology ( Site 0955)

location_facility: Ottawa Hospital Research Institute ( Site 0109)

location_facility: IRCCS Ospedale San Raffaele ( Site 0596)

location_facility: Houston Methodist Urology Associates ( Site 0033)

location_facility: Hamamatsu University Hospital ( Site 1511)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0852)

location_facility: University General Hospital of Larissa ( Site 0302)

location_facility: Yokohama City University Medical Center ( Site 1508)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0871)

location_facility: Gachon University Gil Medical Center ( Site 1356)

location_facility: Rabin Medical Center-Oncology ( Site 0752)

location_facility: Osaka International Cancer Institute ( Site 1514)

location_facility: St.Petersburg State Medical Univ. n.a. acad. I.P.Pavlov ( Site 0856)

location_facility: UT Southwestern Medical Center ( Site 0003)

location_facility: Steve Biko Academic Hospital ( Site 0601)

location_facility: Kyungpook National University Chilgok Hospital ( Site 1354)

location_facility: I.I. Mechnykov Dnipropetrovsk Regional Clinical Hospital ( Site 0959)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento ( Site 0598)

location_facility: Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 0600)

location_facility: Fakultni Thomayerova nemocnice ( Site 0252)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0509)

location_facility: University of Tsukuba Hospital ( Site 1502)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0037)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0867)

location_facility: National Medical Research Centre of Oncology named after N.N. Blokhin ( Site 0865)

location_facility: Altay Regional Oncology Dispensary ( Site 0851)

location_facility: The University of Tennessee Medical Center ( Site 0034)

location_facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0965)

location_facility: Narodowy Instytut Onkologii ( Site 1051)

location_facility: Universitaetsklinikum Muenster ( Site 0516)

location_facility: Nagasaki University Hospital ( Site 1517)

location_facility: Chonnam National University Hwasun Hospital ( Site 1353)

location_facility: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 0660)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1505)

location_facility: National Medical Research Radiology Centre ( Site 0869)

location_facility: Seoul National University Bundang Hospital ( Site 1355)

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole ( Site 0455)

location_facility: MI Clinical oncology dispensary of Dnipropetrovsk regional council ( Site 0954)

location_facility: Osaka City University Hospital ( Site 1515)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 0753)

location_facility: Volgograd Regional Uronephrological Center ( Site 0870)

location_facility: Rambam Health Care Campus-Oncology ( Site 0751)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0463)

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1053)

location_facility: Kanazawa University Hospital ( Site 1509)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0661)

location_facility: Kath. Krankenhaus Marienhospital. Universitaetsklinik ( Site 0511)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 0595)

intervention_type: Procedure


title: Teriparatide and Risedronate in the Treatment of Patients With Severe Postmenopausal Osteoporosis: Comparative Effects on Vertebral Fractures

acronym: VERO

summary: The primary purpose of participation in this study is to answer whether teriparatide is superior to risedronate in reducing the occurrence of new vertebral fractures during 24 months of therapy.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Body JJ, Marin F, Kendler DL, Zerbini CAF, López-Romero P, Möricke R, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Minisola S, Geusens P. Efficacy of teriparatide compared with risedronate on FRAX(®)-defined major osteoporotic fractures: results of the VERO clinical trial. Osteoporos Int. 2020 Oct;31(10):1935-1942. doi: 10.1007/s00198-020-05463-4. Epub 2020 May 30.

family: Body

full_name: J.-J. Body

sequence: first

family: Marin

full_name: F. Marin

given: F.

sequence: additional

family: Kendler

full_name: D.L. Kendler

family: Zerbini

full_name: C.A.F. Zerbini

family: López-Romero

full_name: P. López-Romero

given: P.

family: Möricke

full_name: R. Möricke

given: R.

family: Casado

full_name: E. Casado

given: E.

family: Fahrleitner-Pammer

full_name: A. Fahrleitner-Pammer

given: A.

family: Stepan

full_name: J.J. Stepan

family: Lespessailles

full_name: E. Lespessailles

family: Minisola

full_name: S. Minisola

given: S.

family: Geusens

full_name: P. Geusens

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Osteoporosis International

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Efficacy of teriparatide compared with risedronate on FRAX®-defined major osteoporotic fractures: results of the VERO clinical trial

ReferenceCitation: Geusens P, Kendler DL, Fahrleitner-Pammer A, López-Romero P, Marin F. Distribution of Prevalent and Incident Vertebral Fractures and Their Association with Bone Mineral Density in Postmenopausal Women in the Teriparatide Versus Risedronate VERO Clinical Trial. Calcif Tissue Int. 2020 Jun;106(6):646-654. doi: 10.1007/s00223-020-00683-6. Epub 2020 Mar 10.

full_name: Piet Geusens

given: Piet

full_name: David L. Kendler

given: David L.

full_name: Astrid Fahrleitner-Pammer

given: Astrid

full_name: Pedro López-Romero

given: Pedro

full_name: Fernando Marin

given: Fernando

ReferenceCitation: Minisola S, Marin F, Kendler DL, Geusens P, Zerbini CAF, Russo LA, Casado E, Fahrleitner-Pammer A, Stepan JJ, Lespessailles E, Moericke R, Bagur A, Lakatos P, López-Romero P, Body JJ. Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Arch Osteoporos. 2019 Jan 18;14(1):10. doi: 10.1007/s11657-019-0561-x.

ReferenceCitation: Geusens P, Marin F, Kendler DL, Russo LA, Zerbini CA, Minisola S, Body JJ, Lespessailles E, Greenspan SL, Bagur A, Stepan JJ, Lakatos P, Casado E, Moericke R, López-Romero P, Fahrleitner-Pammer A. Effects of Teriparatide Compared with Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with Severe Osteoporosis: The VERO Trial. J Bone Miner Res. 2018 May;33(5):783-794. doi: 10.1002/jbmr.3384. Epub 2018 Feb 9.

name: Maastricht University Medical Center; Maastricht The Netherlands

name: Lilly Research Center Europe; Madrid Spain

name: University of British Columbia; Vancouver Canada

name: CCBR Brasil Centro de Analises e Pesquisas Clínicas; Rio de Janeiro Brazil

name: Centro Paulista de Investigaçao Clínica; Sao Paulo Brazil

name: Regional Hospital of Orléans; Orléans France

name: Osteoporosis Center; University of Pittsburgh; Pittsburgh PA USA

name: Centro de Osteopatías Comlit; Buenos Aires Argentina

name: Institute of Rheumatology and Faculty of Medicine 1; Charles University; Prague Czech Republic

name: Semmelweis University Medical School; Budapest Hungary

name: University Hospital Parc Taulí Sabadell (UAB); Barcelona Spain

name: Institut Präventive Medizin & Klinische Forschung; Magdeburg Germany

name: Division of Endocrinology and Diabetes; Medical University of Graz; Graz Austria

repository_institution: Semmelweis University - Semmelweis University Repository

ReferenceCitation: Kendler DL, Marin F, Zerbini CAF, Russo LA, Greenspan SL, Zikan V, Bagur A, Malouf-Sierra J, Lakatos P, Fahrleitner-Pammer A, Lespessailles E, Minisola S, Body JJ, Geusens P, Möricke R, López-Romero P. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2018 Jan 20;391(10117):230-240. doi: 10.1016/S0140-6736(17)32137-2. Epub 2017 Nov 9. Erratum in: Lancet. 2017 Nov 30;:. Erratum in: Lancet. 2018 Dec 1;392(10162):2352.

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

location_country:
Italy
Austria
Brazil
Germany
France
Czechia
Greece
Poland
Hungary
Argentina
Belgium
Puerto Rico
Spain
United States
Canada

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Phase 2, Multicenter, Randomized Study of Trastuzumab Deruxtecan in Subjects With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02)

summary: This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Italy
United States
Netherlands
France
Japan
Australia
Spain
Canada
Korea, Republic of
Taiwan

location_facility: Hospital Universitari i PolitÃ¨cnic La Fe

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Assistance Publique Hopitaux de Marseille AP-HM, Hopital NORD

location_facility: Chang Gung Memorial Hospital CGMH - LinKou Branch

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Strutturadi Oncologia

location_facility: Washington University School of Medicine

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Seoul National University Bundang Hospital

location_facility: Henry Ford Cancer Institute/Henry Ford Hospital

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Humanitas Cancer Center Istituto Clinico Humanitas

location_facility: Yonsei University Health System - Severance Hospital

location_facility: University of Colorado Denver - Anschutz Medical Campus

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Hospital Universitario Fundacion Jimenez Diaz


title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy.

summary: This is a Phase III double-blind, placebo-controlled study of Durvalumab versus Placebo in patients with stage II-III NSCLC who are MRD-positive following curative intent therapy.

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

lead_sponsor: AstraZeneca

location_country:
Peru
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Vietnam
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

intervention_type: Other


title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter Combined Phase 2a/2b Study to Assess the Efficacy and Safety of BAY 1817080 in Patients With Diabetic Neuropathic Pain

summary:
People suffering from diabetes often have high blood sugar levels. Over time this can affect many organs including the nerves in hands and feet and can cause a nerve pain called diabetic neuropathic pain (DNP). There are treatments for DNP but in many patients they do not reach a good pain reduction and have unwanted side effects.

In this trial, the researchers will look at how BAY1817080 works and how safe it is. They will compare it to a placebo or another treatment for DNP called pregabalin. A placebo looks like a treatment but does not have any medicine in it. The researchers will use a placebo to learn if the participants' results are due to BAY1817080 or if the results could be due to chance. The researchers will also learn more about the right dose of BAY1817080 for these participants.

The trial will include participants who have DNP and either type 1 or type 2 diabetes. It will include about 440 men and women who are at least 18 years old.

This trial will have 2 parts. In Part 1, the participants will take either BAY1817080 or the placebo. These treatments will be taken as a tablet by mouth twice a day for 8 weeks. In Part 2, participants will take BAY 1817080, pregabalin, or a matching placebo of either treatment. BAY1817080 and a placebo will be taken as a tablet by mouth twice a day for 12 weeks. Pregabalin and a placebo will be taken as a capsule by mouth twice a day for 12 weeks.

The participants in Part 1 will visit their trial site 6 times. The participants in Part 2 will visit their trial site 7 times. At these visits, the doctors will ask the participants if they have any health problems, take blood samples, and do a physical exam. They will also ask the participants to complete questionnaires about their pain and other symptoms.

ipd_sharing_description: Availability of this study's data will later 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.

location_country: Austria Sweden Finland France Czechia Japan Poland Slovakia Norway Hungary Denmark Germany

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

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

location_facility: Center For Diabetes, Academic Specialist Center

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

location_facility: Medical Corporation Kyosokai AMC Nishi-umeda Clinic

location_facility: Japan Red Cross Society Azumino Hospital

location_facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol

location_facility: Liptovska nemocnica s poliklinikou MUDr. Ivana Stodolu

location_facility: Zentrum f. klinische Studien Dr. Hanusch GmbH

location_facility: Turun yliopistollinen keskussairaala, kantasairaala

location_facility: Diamond Clinic Specjalistyczne Poradnie Lekarskie

location_facility: SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

location_facility: DPCKh Orszagos Hematologiai es Infektologiai Intezet

location_facility: Private Diabetologik Praxis Dr. Täschner / Dr. Bonigut

location_facility: Hôpital Gabriel Montpied - Clermont Ferrand

location_facility: Diabetologicka a endokrinologicka ambulance, Milan Kvapil,


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

location_country:
Italy
United States
Hong Kong
Switzerland
Germany
France
Belgium
New Zealand
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

location_facility: Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

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

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Kaiser Permanente - Sacramento; Oncology Pharmacy

location_facility: Sault Area Hospital; Algoma District Cancer Program

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Castle Hill Hospital; The Queen's Centre for Oncology & Haematology

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

location_facility: Kaiser Permanente - San Jose Medical Center

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Kaiser Permanente - Santa Clara; Oncology Clinical trials

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

location_facility: Victoria Hospital - London Health Sciences Centre

location_facility: St. Bernard's Hospital, Inc. d/b/a St. Bernards Medical Center

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil; Servicio de Oncologia

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer

summary:
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).

Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:- Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin

Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).


title: A Double-blind, Placebo-controlled, Randomized Trial to Study the Viaskin Peanut's Efficacy and Safety for Treating Peanut Allergy in Children and Adults.

acronym: VIPES

summary:
The objectives of this dose-finding study for the treatment of peanut allergy are:

To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment.
To evaluate the safety of a long-term treatment with Viaskin Peanut.

ReferenceCitation: Lewis MO, Brown-Whitehorn TF, Cianferoni A, Rooney C, Spergel JM. Peanut-allergic patient experiences after epicutaneous immunotherapy: peanut consumption and impact on QoL. Ann Allergy Asthma Immunol. 2019 Jul;123(1):101-103. doi: 10.1016/j.anai.2019.04.006. Epub 2019 Apr 10.

family: Lewis

full_name: Megan O. Lewis

given: Megan O.

family: Brown-Whitehorn

full_name: Terri F. Brown-Whitehorn

given: Terri F.

family: Cianferoni

full_name: Antonella Cianferoni

given: Antonella

family: Rooney

full_name: Courtney Rooney

given: Courtney

family: Spergel

full_name: Jonathan M. Spergel

given: Jonathan M.

journal_name: Annals of Allergy, Asthma & Immunology

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Sampson HA, Shreffler WG, Yang WH, Sussman GL, Brown-Whitehorn TF, Nadeau KC, Cheema AS, Leonard SA, Pongracic JA, Sauvage-Delebarre C, Assa'ad AH, de Blay F, Bird JA, Tilles SA, Boralevi F, Bourrier T, Hébert J, Green TD, Gerth van Wijk R, Knulst AC, Kanny G, Schneider LC, Kowalski ML, Dupont C. Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity: A Randomized Clinical Trial. JAMA. 2017 Nov 14;318(18):1798-1809. doi: 10.1001/jama.2017.16591.

name: Icahn School of Medicine at Mount Sinai, New York, New York2DBV Technologies, Montrouge, France

family: Sampson

full_name: Hugh A. Sampson

given: Hugh A.

name: Massachusetts General Hospital for Children, Boston

family: Shreffler

full_name: Wayne G. Shreffler

given: Wayne G.

name: University of Ottawa Medical School, Ottawa, Ontario, Canada

family: Yang

full_name: William H. Yang

given: William H.

name: University of Toronto, Toronto, Ontario, Canada

family: Sussman

full_name: Gordon L. Sussman

given: Gordon L.

name: Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania

name: Stanford University School Medicine, Palo Alto, California

family: Nadeau

full_name: Kari C. Nadeau

given: Kari C.

name: Alpha Medical Research, Mississauga, Ontario, Canada

family: Cheema

full_name: Amarjit S. Cheema

given: Amarjit S.

name: Rady Children’s Hospital, University of California, San Diego

family: Leonard

full_name: Stephanie A. Leonard

given: Stephanie A.

name: Ann and Robert H. Lurie Children’s Hospital of Chicago, Chicago, Illinois

family: Pongracic

full_name: Jacqueline A. Pongracic

given: Jacqueline A.

name: Hôpital Saint Vincent de Paul, Lille, France

family: Sauvage-Delebarre

full_name: Christine Sauvage-Delebarre

given: Christine

name: Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio

family: Assa’ad

full_name: Amal H. Assa’ad

given: Amal H.

name: Nouvel Hôpital Civil, Strasbourg, France

family: de Blay

full_name: Frederic de Blay

given: Frederic

name: University of Texas Southwestern Medical Center, Dallas

family: Bird

full_name: J. Andrew Bird

given: J. Andrew

name: Northwest Asthma and Allergy Center, Seattle, Washington

family: Tilles

full_name: Stephen A. Tilles

given: Stephen A.

name: Hôpital Pellegrin-Enfants, Bordeaux, France

name: Hôpitaux Pédiatriques de Nice CHU-Lenval, Nice, France

name: Children’s Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

name: Erasmus Medical Center, Rotterdam, the Netherlands

name: University Medical Center, Utrecht, the Netherlands

name: Hôpitaux de Brabois, University of Lorraine, Vandœuvre-lès-Nancy, France

name: Boston Children’s Hospital, Boston, Massachusetts

name: Medical University of Lodz, Lodz, Poland

name: Hôpital Necker, Enfants Malades, Paris, France26Université Paris-Descartes, Paris, France

location_country:
Netherlands
Poland
France
United States
Canada

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hôpital Pellegrin

location_facility: Ottawa Allergy Asthma Research Institute

location_facility: University of California, Rady Childrens Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Centre de Recherche Appliquée en Asthme et Allergie de Québec


title: Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering From Acute Decompensated Heart Failure [TRUE-AHF]

acronym: TRUE-AHF

summary: The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF).

ReferenceType: background

ReferenceCitation: Mitrovic V, Lüss H, Nitsche K, Forssmann K, Maronde E, Fricke K, Forssmann WG, Meyer M. Effects of the renal natriuretic peptide urodilatin (ularitide) in patients with decompensated chronic heart failure: a double-blind, placebo-controlled, ascending-dose trial. Am Heart J. 2005 Dec;150(6):1239.

ReferenceCitation: Mitrovic V, Seferovic PM, Simeunovic D, Ristic AD, Miric M, Moiseyev VS, Kobalava Z, Nitsche K, Forssmann WG, Lüss H, Meyer M. Haemodynamic and clinical effects of ularitide in decompensated heart failure. Eur Heart J. 2006 Dec;27(23):2823-32. Epub 2006 Oct 30.

ReferenceCitation: Packer M, O'Connor C, McMurray JJV, Wittes J, Abraham WT, Anker SD, Dickstein K, Filippatos G, Holcomb R, Krum H, Maggioni AP, Mebazaa A, Peacock WF, Petrie MC, Ponikowski P, Ruschitzka F, van Veldhuisen DJ, Kowarski LS, Schactman M, Holzmeister J; TRUE-AHF Investigators. Effect of Ularitide on Cardiovascular Mortality in Acute Heart Failure. N Engl J Med. 2017 May 18;376(20):1956-1964. doi: 10.1056/NEJMoa1601895. Epub 2017 Apr 12.

family: Packer

full_name: Milton Packer

given: Milton

family: O’Connor

full_name: Christopher O’Connor

given: Christopher

family: McMurray

full_name: John J.V. McMurray

given: John J.V.

family: Wittes

full_name: Janet Wittes

given: Janet

family: Abraham

full_name: William T. Abraham

given: William T.

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Dickstein

full_name: Kenneth Dickstein

given: Kenneth

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

family: Holcomb

full_name: Richard Holcomb

given: Richard

family: Krum

full_name: Henry Krum

given: Henry

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

family: Mebazaa

full_name: Alexandre Mebazaa

given: Alexandre

family: Peacock

full_name: W. Frank Peacock

given: W. Frank

family: Petrie

full_name: Mark C. Petrie

given: Mark C.

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

family: Ruschitzka

full_name: Frank Ruschitzka

given: Frank

family: van Veldhuisen

full_name: Dirk J. van Veldhuisen

given: Dirk J.

family: Kowarski

full_name: Lisa S. Kowarski

given: Lisa S.

family: Schactman

full_name: Mark Schactman

given: Mark

family: Holzmeister

full_name: Johannes Holzmeister

given: Johannes

journal_name: New England Journal of Medicine

oa_host_type: repository

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Packer M, Holcomb R, Abraham WT, Anker S, Dickstein K, Filippatos G, Krum H, Maggioni AP, McMurray JJV, Mebazaa A, O'Connor C, Peacock F, Ponikowski P, Ruschitzka F, van Veldhuisen DJ, Holzmeister J; TRUE-AHF Investigators and Committees. Rationale for and design of the TRUE-AHF trial: the effects of ularitide on the short-term clinical course and long-term mortality of patients with acute heart failure. Eur J Heart Fail. 2017 May;19(5):673-681. doi: 10.1002/ejhf.698. Epub 2016 Nov 13.

name: Baylor Heart and Vascular Institute; Baylor University Medical Center; Dallas TX USA

name: Ohio State University Heart and Vascular Center; Columbus OH USA

name: Innovative Clinical Trials, Department of Cardiology & Pneumology; University Medical Center Göttingen (UMG); Göttingen Germany

name: Division of Cardiology; University of Bergen; Stavanger Norway

name: National and Kapodistrian University of Athens, School of Medicine; Attikon Athens University Hospital, Department of Cardiology; Athens Greece

name: Monash University; Centre of Cardiovascular Research & Education in Therapeutics; Melbourne Australia

name: Centro Studi ANMCO; Fondazione ‘per il Tuo cuore’ HCF ONLUS; Firenze Italy

name: Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre; University of Glasgow; Glasgow UK

name: University of Paris, Department of Anesthesia and Critical Care; Hôpitaux Universitaire Saint Louis Lariboisière; Paris France

name: Inova Heart and Vascular Institute; Falls Church VA USA

name: Baylor College of Medicine; Houston TX USA

name: Poland Wroclaw Medical University; Wroclaw Poland

name: Cardiology; University Hospital Zurich; Zurich Switzerland

name: University Medical Center Groningen; Groningen The Netherlands

name: on behalf of the TRUE-AHF Investigators and Committees

location_country:
Finland
Romania
Belgium
France
Poland
Lithuania
Argentina
Canada
Turkey
Switzerland
Netherlands
Hungary
United States
Germany
Italy
Brazil
Serbia
Czechia
Israel
Spain
Estonia
Latvia


title: A Randomized, Phase 2, Double-blind Study to Evaluate the Efficacy of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Metastatic Non-Squamous Non-Small Cell Lung Cancer

summary: NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
Germany
France
Poland
Romania
Argentina
Spain
United States
Korea, Republic of
Taiwan


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)

summary: This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Italy
Netherlands
Germany
France
Czechia
Japan
Poland
Ireland
Belgium
Australia
Spain
United States
United Kingdom
Ukraine

location_facility: Ospedale Civile S. Agostino Estense di Modena, Azienda Ospedaliero Universitaria di Modena

location_facility: Universitaire Ziekenhuizen Leuven (UZ Leuven)

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: National Hospital Organization Omuta National Hospital

location_facility: National Hospital Organization Okinawa National Hospital

location_facility: Medizinische Hochschule Hannover Klinik für Neurologie

location_facility: Universitätsmedizin Rostock, Klinik und Poliklinik für Neurologie

location_facility: National Hospital Organization Iou National Hospital

location_facility: Niigata National Hospital National Hospital Organization

location_facility: Ospedale Niguarda - Nemo Clinical Center - Fondazione Serena Onlus

location_facility: National Hospital Organization Hyogo-Chuo National Hospital

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Centre of Reconstructive and Restorative Medicine (University Clinic) Odessa National Medical University

location_facility: Uniwersytecki Szpital Kliniczny w Olsztynie Klinika Neurologii

location_facility: University Hospitals Sussex NHS Foundation Trust

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: National Hospital Organization Higashisaitama National Hospital

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

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: Maurice Wohl Clinical Neuroscience Institute, King's College London

location_facility: National Hospital Organization Higashinagoya National Hospital

location_facility: Nueor-Immunology Clinical Researh Education and Support Service (N-CRESS), Austin Health


title: A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression

summary: This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

design_allocation: Non-Randomized

lead_sponsor: Seagen Inc.

location_country:
Italy
France
Spain
United States
United Kingdom

location_facility: CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Illinois Cancer Specialists / Advocate Lutheran General Hospital

location_facility: Azienda Ospedaliero-Universitaria di Bologna - IRCCS

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Virginia Commonwealth University Medical Center

location_facility: Virginia Oncology Associates - Virginia Beach

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

location_facility: Stanford Cancer Center / Blood and Marrow Transplant Program

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: MD Anderson Cancer Center / University of Texas


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

acronym: LUNA 3

summary:
This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily.

For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. There is a 4-week post dose follow-up.

Patients who respond per specified criteria at the end of the Open-Label Period will be able to enter a 12-month Long-Term Extension (LTE).

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

lead_sponsor: Principia Biopharma, a Sanofi Company

location_country:
Australia
Russian Federation
Ukraine
France
Poland
Thailand
Norway
Argentina
Korea, Republic of
Chile
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
Spain
Turkey

location_facility:
Investigational Site Number 76401
Investigational Site Number 64307
Investigational Site Number 84026
Investigational Site Number 57801
Investigational Site Number 04005
Investigational Site Number 15201
Investigational Site Number 84020
Investigational Site Number 03205
Investigational Site Number 38010
Investigational Site Number 41006
Investigational Site Number 03606
Investigational Site Number 80409
Investigational Site Number 38012
Investigational Site Number 04004
Investigational Site Number 79210
Investigational Site Number 37607
Investigational Site Number 82605
Investigational Site Number 64306
Investigational Site Number 04003
Investigational Site Number 70202
Investigational Site Number 64304
Investigational Site Number 84027
Investigational Site Number 57802
Investigational Site Number 07607
Investigational Site Number 72407
Investigational Site Number 79209
Investigational Site Number 25011
Investigational Site Number 41001
Investigational Site Number 04002
Investigational Site Number 25010
Investigational Site Number 41005
Investigational Site Number 27613
Investigational Site Number 07605
Investigational Site Number 07608
Investigational Site Number 03611
Investigational Site Number 07609
Investigational Site Number 38015
Investigational Site Number 37605
Investigational Site Number 72411
Investigational Site Number 80408
Investigational Site Number 03208
Investigational Site Number 34802
Investigational Site Number 07610
Investigational Site Number 64303
Investigational Site Number 07611
Investigational Site Number 41004
Investigational Site Number 76403
Investigational Site Number 03608
Investigational Site Number 34805
Investigational Site Number 76402
Investigational Site Number 84029
Investigational Site Number 27611
Investigational Site Number 76405
Investigational Site Number 61609
Investigational Site Number 37606
Investigational Site Number 72412
Investigational Site Number 37609
Investigational Site Number 70203
Investigational Site Number 25012
Investigational Site Number 38011
Investigational Site Number 03209
Investigational Site Number 03610
Investigational Site Number 64301
Investigational Site Number 64302
Investigational Site Number 27610
Investigational Site Number 03609
Investigational Site Number 03206
Investigational Site Number 84028
Investigational Site Number 04001
Investigational Site Number 84024
Investigational Site Number 37608
Investigational Site Number 61615
Investigational Site Number 03607
Investigational Site Number 07606
Investigational Site Number 25007
Investigational Site Number 25008
Investigational Site Number 70201
Investigational Site Number 34804
Investigational Site Number 15202
Investigational Site Number 84023
Investigational Site Number 41003
Investigational Site Number 72409
Investigational Site Number 72408
Investigational Site Number 79206
Investigational Site Number 25009


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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
Netherlands
Germany
France
Czechia
Japan
Hungary
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

acronym: APPLY-PNH

title: A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of Oral, Twice Daily LNP023 in Adult Patients With PNH and Residual Anemia, Despite Treatment With an Intravenous Anti-C5 Antibody.

summary: The purpose of this Phase 3 study is to determine whether LNP023 is efficacious and safe for the treatment in PNH through demonstration of superiority of LNP023 compared to anti-C5 antibody treatment in adult PNH patients presenting with residual anemia despite treatment with anti-C5 therapy


title: A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches

acronym: PANTHER

summary:
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.

Data will be collected both retrospectively and prospectively.

study_type: Observational

time_perspective: Other

lead_sponsor: Vascutek Ltd.

location_country:
United States
Netherlands
France
Hungary
Belgium
Germany

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: University of South Florida - Tampa General

location_facility: Semmelweis University Heart and Vascular Center

location_facility: University Hospitals Cleveland Medical Center

location_facility: Universitätsmedizin Mainz (University Hospital Mainz)

location_facility: Ludwig-Maximilian Universität (LMU) Klinikum

intervention_type: Device


title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.

acronym: FENtrepid

summary: A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

location_country:
Peru
Greece
Australia
Russian Federation
Denmark
Ukraine
France
Poland
Argentina
Canada
Colombia
Hungary
Puerto Rico
Portugal
United States
United Kingdom
Austria
Brazil
Mexico
Israel
Spain
Turkey

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Dr. HIBBEY Egeszsegugyi es Szolgaltato Kft

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Vero Beach Neurology and Research Institute

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Uni of Texas Health Science Center At Houston

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Federal center of brain research and neurotechnologies

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: Hospital Alvaro Cunqueiro; Servicio de Neurologia

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: CNPE City Clinical Hospital #3 of Chernivtsi City Council

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Regional health authority A vitalite health network

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Box Hill Hospital; Department of Neurology

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: OhioHealth Riverside Methodist Hospital; Pharmacy Services

location_facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Atrium Health Neurosciences Institute - Charlotte

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: City Hospital #40 of Resort Administrative District

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Municipal Institution Dnipropetrovsk Regional Clinical Hospital n a I I Mechnykov; Neurology dept #1

location_facility: Johns Hopkins University School Of Medicine; Outpatient Center

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Instituto De Neurología Cognitiva - INECO

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Medical Centre of PE First Private Clinic

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

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

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Hopital Civil de Strasbourg; Service de Neurologie

location_facility: Odesa Regional Clinical Hospital; Neurosurgery Department

location_facility: Fraser Health Authority - Fraser Health Multiple Sclerosis

location_facility: National Center of Social Significant Disease

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: Texas Institute for Neurological Disorders

location_facility: Austin Hospital; Department of Neurology

location_facility: Hospital de Sao Joao; Servico de Neurologia

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital Vall de Hebrón; Servicio de Neurologia. Centre d'Esclerosi Multiple de Catalunya CEMCAT

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology


title: A Phase 1/2 Study to Compare Bempegaldesleukin Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)

acronym: PIVOT IO 011

summary: The purpose of this study is to first, in Part 1, to determine the safety of nivolumab, bempegaldesleukin (BEMPEG: NKTR-214), and Tyrosine Kinase Inhibitor (TKI) combination and then, in Part 2, to evaluate the effectiveness of nivolumab, bempegaldesleukin, and cabozantinib when compared with nivolumab and cabozantinib in participants with previously untreated kidney cancer that has advanced or has spread.

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
United States
Mexico
Germany
France
Argentina
Russian Federation
Spain
Canada

location_facility: Washington University School Of Medicine

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: University of Texas MD Anderson Cancer Center


status: Active, not recruiting

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
France
Russian Federation
Belgium
Spain
United States

location_facility: Texas Oncology, P.A. - Austin - Austin Central Cancer Center

location_facility: UPMC Hillman Cancer Center - Hillman Cancer Center

location_facility: SBIH " Clinical Oncological Dispensary 1" - Location

location_facility: Centre François Baclesse - Pathologies Gynecologiques

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Hospital Universitario Ramon y Cajal - Servicio de Oncologia

location_facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow Cancer Research Centre

location_facility: Tomsk Research Instutite of Oncology - Chemotherapy

location_facility: TheOhio State University, Stefanie Spielman Comprehensive Breast Center

location_facility: Hospital Universitario Reina Sofia - Dept of Oncology

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" - Chemotherapy

location_facility: Hospital Ruber Internacional - Servicio de Oncologia

location_facility: FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

location_facility: New York Oncology Hematology, P.C. - Albany

location_facility: Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento di Senologia

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Institut Curie - Centre René Huguenin - Service d'Oncologie Médicale

location_facility: SBIH " Clinical Oncological Dispensary # 1" - Location

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

location_facility: Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: Texas Oncology, P.A. - Medical City Dallas - Pediatric Hematology/Oncology

location_facility: Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

summary: The main purpose of this study is to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With Ruxolitinib in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (Post-PV-MF), Or Post-Essential Thrombocythemia MF (Post ET-MF) Who Have a Suboptimal Response to Ruxolitinib

summary: This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Italy
United States
France
Bulgaria
Poland
Australia
Spain
Germany

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: University Mutiprofile Hospital Alexandrovska

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: d'Hebron University Hospital in Barcelona

location_facility: Department für Innere Medizin Universitätsklinik und Poliklinik für Innere Medizin IV Hämatologie/Onkologie

location_facility: Oddział Kliniczny Hematologii Szpitala Uniwersyteckiego w Krakowie

location_facility: Szpital Wojewódzki w Opolu Sp zooOddzial Kliniczny Hematologii

location_facility: Universitätsklinikum Aachen Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz III. Med. Klinik und Poliklinik