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

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

location_country:
Finland
Greece
Belgium
Russian Federation
Denmark
Croatia
France
Lithuania
Poland
Slovakia
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Latvia

acronym: OPTIMISE

title: Long Term Clear Skin Maintenance Treatment Optimization in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Multicenter, Open-label With Blinded-assessment, Comparative, 52 Week Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg s.c.

summary: To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.


ReferenceType: derived

ReferenceCitation: Ferris RL, Haddad R, Even C, Tahara M, Dvorkin M, Ciuleanu TE, Clement PM, Mesia R, Kutukova S, Zholudeva L, Daste A, Caballero-Daroqui J, Keam B, Vynnychenko I, Lafond C, Shetty J, Mann H, Fan J, Wildsmith S, Morsli N, Fayette J, Licitra L. Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study. Ann Oncol. 2020 Jul;31(7):942-950. doi: 10.1016/j.annonc.2020.04.001. Epub 2020 Apr 12.

family: Ferris

full_name: R.L. Ferris

sequence: first

family: Haddad

full_name: R. Haddad

given: R.

sequence: additional

family: Even

full_name: C. Even

given: C.

family: Tahara

full_name: M. Tahara

given: M.

family: Dvorkin

full_name: M. Dvorkin

family: Ciuleanu

full_name: T.E. Ciuleanu

family: Clement

full_name: P.M. Clement

family: Mesia

full_name: R. Mesia

family: Kutukova

full_name: S. Kutukova

given: S.

family: Zholudeva

full_name: L. Zholudeva

given: L.

family: Daste

full_name: A. Daste

given: A.

family: Caballero-Daroqui

full_name: J. Caballero-Daroqui

given: J.

family: Keam

full_name: B. Keam

given: B.

family: Vynnychenko

full_name: I. Vynnychenko

given: I.

family: Lafond

full_name: C. Lafond

family: Shetty

full_name: J. Shetty

family: Mann

full_name: H. Mann

given: H.

family: Fan

full_name: J. Fan

family: Wildsmith

full_name: S. Wildsmith

family: Morsli

full_name: N. Morsli

given: N.

family: Fayette

full_name: J. Fayette

family: Licitra

full_name: L. Licitra

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Sumy State University - Electronic Sumy State University Institutional Repository

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

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

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
Croatia
France
Japan
Poland
Argentina
Korea, Republic of
Chile
Bulgaria
Hungary
Germany
United States
Italy
Brazil
Serbia
Czechia
Israel
Georgia
Spain

title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.


type: Other Identifier

type: EudraCT Number

title: A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome

acronym: GEMINI ACS 1

summary: The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction [STEMI] and non-ST-segment elevation acute coronary syndrome [NSTE-ACS]).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

family: Gibson

full_name: William J. Gibson

given: William J.

family: Nafee

full_name: Tarek Nafee

given: Tarek

family: Travis

full_name: Ryan Travis

given: Ryan

family: Yee

full_name: Megan Yee

given: Megan

family: Kerneis

full_name: Mathieu Kerneis

given: Mathieu

family: Ohman

full_name: Magnus Ohman

given: Magnus

full_name: C. Michael Gibson

given: C. Michael

journal_name: Journal of Thrombosis and Thrombolysis

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina

family: Povsic

full_name: Thomas J. Povsic

given: Thomas J.

full_name: E. Magnus Ohman

given: E. Magnus

family: Roe

full_name: Matthew T. Roe

given: Matthew T.

family: White

full_name: Jennifer White

given: Jennifer

family: Rockhold

full_name: Frank W. Rockhold

given: Frank W.

name: Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris, France

family: Montalescot

full_name: Gilles Montalescot

given: Gilles

name: Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar and Dutch Network for Cardiovascular Research, the Netherlands

family: Cornel

full_name: Jan H. Cornel

given: Jan H.

name: Insituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil

family: Nicolau

full_name: Jose C. Nicolau

given: Jose C.

name: DHU FIRE, Université Paris-Diderot, AP-HP and Inserm U-1148, Paris, France

name: National Heart and Lung Institute Royal Brompton Hospital, Imperial College, London, England

family: Steg

full_name: P. Gabriel Steg

given: P. Gabriel

name: Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden

family: James

full_name: Stefan James

given: Stefan

name: University of Freiburg, Faculty of Medicine, Internal Medicine III, Freiburg, Germany

family: Bode

full_name: Christoph Bode

given: Christoph

name: Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada

family: Welsh

full_name: Robert C. Welsh

given: Robert C.

name: Janssen Research and Development, Raritan, New Jersey

family: Plotnikov

full_name: Alexei N. Plotnikov

given: Alexei N.

name: PERFUSE Study Group, Beth Israel Deaconess Hospital, Harvard Medical School, Boston, Massachusetts

ReferenceCitation: Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Güray Ü, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.

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

ReferenceCitation: Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

location_country:
Brazil
Sweden
Netherlands
Spain
France
Bulgaria
Czechia
Japan
Korea, Republic of
Poland
Hungary
Belgium
Argentina
Australia
Russian Federation
Turkey
Denmark
United States
Canada
Ukraine


ReferenceCitation: Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kong S, Lee A, Coleman S, Zou W, McCleland M, Shankar G, Reck M. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2021 Nov;16(11):1909-1924. doi: 10.1016/j.jtho.2021.07.009. Epub 2021 Jul 24.

family: Socinski

full_name: Mark A. Socinski

given: Mark A.

family: Nishio

full_name: Makoto Nishio

given: Makoto

family: Jotte

full_name: Robert M. Jotte

given: Robert M.

family: Cappuzzo

full_name: Federico Cappuzzo

given: Federico

family: Orlandi

full_name: Francisco Orlandi

given: Francisco

family: Stroyakovskiy

full_name: Daniil Stroyakovskiy

given: Daniil

family: Nogami

full_name: Naoyuki Nogami

given: Naoyuki

family: Rodríguez-Abreu

full_name: Delvys Rodríguez-Abreu

given: Delvys

family: Moro-Sibilot

full_name: Denis Moro-Sibilot

given: Denis

family: Thomas

full_name: Christian A. Thomas

given: Christian A.

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Finley

full_name: Gene Finley

given: Gene

family: Kong

full_name: Shengchun Kong

given: Shengchun

family: Lee

full_name: Anthony Lee

given: Anthony

family: Coleman

full_name: Shelley Coleman

given: Shelley

family: Zou

full_name: Wei Zou

given: Wei

family: McCleland

full_name: Mark McCleland

given: Mark

family: Shankar

full_name: Geetha Shankar

given: Geetha

family: Reck

full_name: Martin Reck

given: Martin

journal_name: Journal of Thoracic Oncology

oa_host_type: publisher

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Reck M, Wehler T, Orlandi F, Nogami N, Barone C, Moro-Sibilot D, Shtivelband M, González Larriba JL, Rothenstein J, Früh M, Yu W, Deng Y, Coleman S, Shankar G, Patel H, Kelsch C, Lee A, Piault E, Socinski MA. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27.

name: Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Grosshansdorf, Germany

name: Evangelisches Krankenhaus Hamm gGmbH, Hamm, Germany

family: Wehler

full_name: Thomas Wehler

given: Thomas

name: Instituto Nacional del Tórax, Santiago, Chile

name: Università Cattolica del Sacro Cuore, Rome, Italy

name: Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France

name: Ironwood Cancer & Research Center, Chandler, AZ

name: Hospital Clínico San Carlos, Madrid, Spain

name: Durham Regional Cancer Center, Lakeridge Health, Oshawa, Ontario, Canada

name: Cantonal Hospital of St Gallen, St Gallen, Switzerland

name: AdventHealth Cancer Institute, Orlando, FL

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non–Small-Cell Lung Cancer

ReferenceCitation: Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Lee A, Coleman S, Deng Y, Kowanetz M, Shankar G, Lin W, Socinski MA; IMpower150 Study Group. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019 May;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0. Epub 2019 Mar 25.

ReferenceCitation: Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.

name: From the Florida Hospital Cancer Institute, Orlando (M.A.S.); Rocky Mountain Cancer Centers, Denver (R.M.J.); US Oncology, Houston (R.M.J.); Azienda Unità Sanitaria Locale della Romagna, Ravenna, Italy (F.C.); Instituto Nacional del Torax, Santiago, Chile (F.O.); Moscow City Oncology Hospital, Moscow (D.S.); National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan (N.N.); Complejo Hospitalario Universitario Insular Materno-Infantil de Gran Canaria, Universidad de Las Palmas de Gran Canaria,...

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

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

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

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: West Virginia University; Mary Babb Randolph Can Ctr

location_facility: Centro Especializado de Enfermedades Neoplásicas

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

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

location_facility: St. Charles Medical Center Bend; Cancer Care Of The Cascades

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: Cancer Specialists of North Florida - Baptist South

location_facility: Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

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

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

location_facility: Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon

location_facility: Universität Des Saarlandes; Klinik für Innere Medizin V

location_facility: Chao Family Comprehensive Cancer Center UCI

location_facility: IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

location_facility: Park Nicolett - Frauenshuh Cancer Center

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

location_facility: National Cancer Centre; Medical Oncology

location_facility: Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Willamette Valley Cancer Insitute and Research Center

location_facility: Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Centre Jean Bernard Clinique Victor Hugo

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

location_facility: Prince Charles Hospital; Department of Medical Oncology

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

location_facility: Hospital Universitario Fundación Jimenez Díaz

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: MNPE Transcarpathian Antitumor Center of the Transcarpathian Regional Council; Chemotherapy Dept

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Fundación CENIT para la Investigación en Neurociencias

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

location_facility: University of Texas Health Science Center at San Antonio

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

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

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

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

location_facility: Centro Hemato Oncologico Privado; Oncologia

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

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

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

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: MNPE Zaporizhzhia Regional Antitumor Center ZRC

location_facility: Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica

title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

summary: This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).


title: A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Ipilimumab Versus Sunitinib Monotherapy in Subjects With Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma

summary: The purpose of this study is to compare the objective response rate, progression free survival and the overall survival of Nivolumab combined with Ipilimumab to Sunitinib monotherapy in patients with previously untreated Renal Cell Cancer.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthélémy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Leung D, Saggi SS, Lee CW, McHenry MB, Motzer RJ. First-line Nivolumab plus Ipilimumab Versus Sunitinib in Patients Without Nephrectomy and With an Evaluable Primary Renal Tumor in the CheckMate 214 Trial. Eur Urol. 2021 Nov 5. pii: S0302-2838(21)02069-8. doi: 10.1016/j.eururo.2021.10.001. [Epub ahead of print]

family: Albiges

full_name: Laurence Albiges

given: Laurence

family: Tannir

full_name: Nizar M. Tannir

given: Nizar M.

family: Burotto

full_name: Mauricio Burotto

given: Mauricio

family: McDermott

full_name: David McDermott

given: David

family: Plimack

full_name: Elizabeth R. Plimack

given: Elizabeth R.

family: Barthélémy

full_name: Philippe Barthélémy

given: Philippe

family: Porta

full_name: Camillo Porta

given: Camillo

family: Powles

full_name: Thomas Powles

family: Donskov

full_name: Frede Donskov

given: Frede

family: George

full_name: Saby George

given: Saby

family: Kollmannsberger

full_name: Christian K. Kollmannsberger

given: Christian K.

family: Gurney

full_name: Howard Gurney

given: Howard

family: Grimm

full_name: Marc-Oliver Grimm

given: Marc-Oliver

family: Tomita

full_name: Yoshihiko Tomita

given: Yoshihiko

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Rini

full_name: Brian I. Rini

given: Brian I.

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Leung

full_name: David Leung

family: Saggi

full_name: Shruti Shally Saggi

given: Shruti Shally

full_name: Chung-Wei Lee

given: Chung-Wei

family: McHenry

full_name: M. Brent McHenry

given: M. Brent

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

ReferenceCitation: Albiges L, Tannir NM, Burotto M, McDermott D, Plimack ER, Barthélémy P, Porta C, Powles T, Donskov F, George S, Kollmannsberger CK, Gurney H, Grimm MO, Tomita Y, Castellano D, Rini BI, Choueiri TK, Saggi SS, McHenry MB, Motzer RJ. Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial. ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, Arén Frontera O, Melichar B, Powles T, Donskov F, Plimack ER, Barthélémy P, Hammers HJ, George S, Grünwald V, Porta C, Neiman V, Ravaud A, Choueiri TK, Rini BI, Salman P, Kollmannsberger CK, Tykodi SS, Grimm MO, Gurney H, Leibowitz-Amit R, Geertsen PF, Amin A, Tomita Y, McHenry MB, Saggi SS, Tannir NM. Survival outcomes and independent response assessment with nivolumab plus ipilimumab versus sunitinib in patients with advanced renal cell carcinoma: 42-month follow-up of a randomized phase 3 clinical trial. J Immunother Cancer. 2020 Jul;8(2). pii: e000891. doi: 10.1136/jitc-2020-000891. Erratum in: J Immunother Cancer. 2021 May;9(5):.

ReferenceCitation: Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

name: Evidence Synthesis, Modeling, & Communications, Evidera, Inc., Bethesda, MD 20814, USA

name: Health Economics Outcomes Research, Bristol-Myers Squibb, Princeton, NJ 08540, USA

name: Department of Internal Medicine – Medical Oncology, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC 20007-2113, USA

name: Evidence Synthesis, Modeling, & Communications, Evidera, Inc., Waltham, MA 20814, USA

name: Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA

name: Department of Medicine, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA 02215, USA

name: Massachusetts General Hospital Cancer Center, Boston, MA 02214, USA

ReferenceCitation: Tomita Y, Kondo T, Kimura G, Inoue T, Wakumoto Y, Yao M, Sugiyama T, Oya M, Fujii Y, Obara W, Motzer RJ, Uemura H. Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: analysis of Japanese patients in CheckMate 214 with extended follow-up. Jpn J Clin Oncol. 2020 Jan 24;50(1):12-19. doi: 10.1093/jjco/hyz132.

name: Department of Urology, Niigata University, Niigata, Japan

name: Department of Urology, Yamagata University Hospital, Yamagata, Japan

name: Department of Urology, Tokyo Women’s Medical University Hospital, Tokyo, Japan

name: Department of Urology, Nippon Medical School Hospital, Tokyo, Japan

name: Department of Urology, Akita University Hospital, Akita, Japan

name: Department of Urology, Juntendo University Hospital, Tokyo, Japan

name: Department of Urology, Yokohama City University Hospital, Yokohama, Japan

name: Department of Urology, Hamamatsu University Hospital, Hamamatsu, Japan

name: Department of Urology, Keio University Hospital, Tokyo, Japan

name: Department of Surgery, Urology, Tokyo Medical and Dental University Hospital, University Hospital of Medicine, Tokyo, Japan

name: Department of Urology, Iwate Medical University Hospital, Morioka, Japan

name: Department of Medicine, Memorial Sloan Kettering Cancer, New York, NY, USA

name: Department of Urology, Kinki University Hospital, Faculty of Medicine, Osakasayama, Japan

ReferenceCitation: Motzer RJ, Rini BI, McDermott DF, Arén Frontera O, Hammers HJ, Carducci MA, Salman P, Escudier B, Beuselinck B, Amin A, Porta C, George S, Neiman V, Bracarda S, Tykodi SS, Barthélémy P, Leibowitz-Amit R, Plimack ER, Oosting SF, Redman B, Melichar B, Powles T, Nathan P, Oudard S, Pook D, Choueiri TK, Donskov F, Grimm MO, Gurney H, Heng DYC, Kollmannsberger CK, Harrison MR, Tomita Y, Duran I, Grünwald V, McHenry MB, Mekan S, Tannir NM; CheckMate 214 investigators. Nivolumab plus ipilimumab versus sunitinib in first-line treatment for advanced renal cell carcinoma: extended follow-up of efficacy and safety results from a randomised, controlled, phase 3 trial. Lancet Oncol. 2019 Oct;20(10):1370-1385. doi: 10.1016/S1470-2045(19)30413-9. Epub 2019 Aug 16. Erratum in: Lancet Oncol. 2019 Aug 21;:. Erratum in: Lancet Oncol. 2020 Jun;21(6):e304. Lancet Oncol. 2020 Nov;21(11):e518.

repositories:
PubMed Central
Pure (Denmark)
ricerca.uniba.it

ReferenceCitation: Cella D, Grünwald V, Escudier B, Hammers HJ, George S, Nathan P, Grimm MO, Rini BI, Doan J, Ivanescu C, Paty J, Mekan S, Motzer RJ. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):297-310. doi: 10.1016/S1470-2045(18)30778-2. Epub 2019 Jan 15. Erratum in: Lancet Oncol. 2019 Jun;20(6):e293.

ReferenceCitation: Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK, Plimack ER, Barthélémy P, Porta C, George S, Powles T, Donskov F, Neiman V, Kollmannsberger CK, Salman P, Gurney H, Hawkins R, Ravaud A, Grimm MO, Bracarda S, Barrios CH, Tomita Y, Castellano D, Rini BI, Chen AC, Mekan S, McHenry MB, Wind-Rotolo M, Doan J, Sharma P, Hammers HJ, Escudier B; CheckMate 214 Investigators. Nivolumab plus Ipilimumab versus Sunitinib in Advanced Renal-Cell Carcinoma. N Engl J Med. 2018 Apr 5;378(14):1277-1290. doi: 10.1056/NEJMoa1712126. Epub 2018 Mar 21.

name: From Memorial Sloan Kettering Cancer Center, New York (R.J.M.), and Roswell Park Cancer Institute, Buffalo (S.G.) — both in New York; University of Texas M.D. Anderson Cancer Center, Houston (N.M.T., P. Sharma); Beth Israel Deaconess Medical Center, Dana–Farber/Harvard Cancer Center (D.F.M.), and Dana–Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School (T.K.C.), Boston; Centro Internacional de Estudios Clínicos (O.A.F.) and Fundación Arturo López Pérez (P. Salman), Santiago,...

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

location_country:
Finland
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Netherlands
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Smilow Cancer Hospital. At Yale New Haven

location_facility: University of Pittsburgh Cancer Institute Cancer Services

location_facility: Winship Cancer Institute, Emory University

location_facility: Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori

location_facility: Centro de Investigacion Clinica Bradford Hill

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: H. Lee Moffitt Cancer Center & Research Inst, Inc

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: Indiana University Health Melvin And Bren Simon Cancer Center

location_facility: Erlanger Oncology & Hematology - Univ. of TN

location_facility: Centro De Cancer, Pontificia Universidad Catolica

location_facility: University Of Iowa Hospitals And Clinics


title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

ReferenceCitation: Plesner T, Dimopoulos MA, Oriol A, San-Miguel J, Bahlis NJ, Rabin N, Suzuki K, Yoon SS, Ben-Yehuda D, Cook G, Goldschmidt H, Grosicki S, Qin X, Fastenau J, Garvin W, Carson R, Renaud T, Gries KS. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial. Br J Haematol. 2021 Jul;194(1):132-139. doi: 10.1111/bjh.17435. Epub 2021 Apr 6.

name: Vejle Hospital and University of Southern Denmark Vejle Denmark

family: Plesner

full_name: Torben Plesner

given: Torben

name: National and Kapodistrian University of Athens School of Medicine Athens Greece

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

name: Institut Català d'Oncologia and Institut Josep Carreras Hospital Germans Trias i Pujol BarcelonaSpain

family: Oriol

full_name: Albert Oriol

given: Albert

name: Clinica Universidad de Navarra Pamplona Spain

family: San‐Miguel

full_name: Jesus San‐Miguel

given: Jesus

name: Tom Baker Cancer Centre Calgary AB Canada

family: Bahlis

full_name: Nizar J. Bahlis

given: Nizar J.

name: Department of Haematology University College London Hospitals NHS Trust London UK

family: Rabin

full_name: Neil Rabin

given: Neil

name: Department of Hematology Japanese Red Cross Medical Center Tokyo Japan

family: Suzuki

full_name: Kenshi Suzuki

given: Kenshi

name: Department of Internal Medicine Seoul National University College of Medicine Seoul South Korea

family: Yoon

full_name: Sung‐Soo Yoon

given: Sung‐Soo

name: Hematology Department Hadassah‐Hebrew University Medical Center Jerusalem Israel

family: Ben‐Yehuda

full_name: Dina Ben‐Yehuda

given: Dina

family: Cook

full_name: Gordon Cook

given: Gordon

name: Internal Medicine VUniversity Hospital Heidelberg and National Center for Tumor Diseases (NCT) Heidelberg Germany

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

name: Medical University of Silesia Katowice Poland

family: Grosicki

full_name: Sebastian Grosicki

given: Sebastian

name: Janssen Research & Development Spring House PA USA

family: Qin

full_name: Xiang Qin

given: Xiang

family: Fastenau

full_name: John Fastenau

given: John

family: Garvin

full_name: Wendy Garvin

given: Wendy

family: Carson

full_name: Robin Carson

given: Robin

family: Renaud

full_name: Thomas Renaud

given: Thomas

family: Gries

full_name: Katharine S. Gries

given: Katharine S.

journal_name: British Journal of Haematology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Health‐related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial

ReferenceCitation: Avet-Loiseau H, San-Miguel J, Casneuf T, Iida S, Lonial S, Usmani SZ, Spencer A, Moreau P, Plesner T, Weisel K, Ukropec J, Chiu C, Trivedi S, Amin H, Krevvata M, Ramaswami P, Qin X, Qi M, Sun S, Qi M, Kobos R, Bahlis NJ. Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR. J Clin Oncol. 2021 Apr 1;39(10):1139-1149. doi: 10.1200/JCO.20.01814. Epub 2021 Jan 29.

name: Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France

family: Avet-Loiseau

full_name: Hervé Avet-Loiseau

given: Hervé

name: Clínica Universidad de Navarra-CIMA, IDISNA, CIBERONC, Pamplona, Spain

family: San-Miguel

full_name: Jesus San-Miguel

name: Janssen Research & Development, Beerse, Belgium

name: Department of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan

name: Winship Cancer Institute, Emory University, Atlanta, GA

name: Levine Cancer Institute/Atrium Health, Charlotte, NC

name: Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia

name: Hematology, University Hospital Hôtel-Dieu, Nantes, France

name: Vejle Hospital and University of Southern Denmark, Vejle, Denmark

name: University Medical Center of Hamburg-Eppendorf, Hamburg, Germany

name: Janssen Scientific Affairs, LLC, Horsham, PA

name: Janssen Research & Development, LLC, Spring House, PA

name: Janssen Research & Development, LLC, Raritan, NJ

name: Janssen Research & Development, LLC, Titusville, NJ

name: University of Calgary, Arnie Charbonneau Cancer Institute, Calgary, AB, Canada

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

ReferenceCitation: Mateos MV, Spencer A, Nooka AK, Pour L, Weisel K, Cavo M, Laubach JP, Cook G, Iida S, Benboubker L, Usmani SZ, Yoon SS, Bahlis NJ, Chiu C, Ukropec J, Schecter JM, Qin X, O'Rourke L, Dimopoulos MA. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies. Haematologica. 2020 Jan 31;105(2):468-477. doi: 10.3324/haematol.2019.217448. Print 2020.

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331.

location_country:
United States
Sweden
Netherlands
Germany
France
Japan
Greece
Israel
Poland
Belgium
Australia
Russian Federation
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan


ReferenceType: background

ReferenceCitation: Mascarenhas J, Hoffman R, Talpaz M, Gerds AT, Stein B, Gupta V, Szoke A, Drummond M, Pristupa A, Granston T, Daly R, Al-Fayoumi S, Callahan JA, Singer JW, Gotlib J, Jamieson C, Harrison C, Mesa R, Verstovsek S. Pacritinib vs Best Available Therapy, Including Ruxolitinib, in Patients With Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):652-659. doi: 10.1001/jamaoncol.2017.5818.

ReferenceCitation: Tremblay D, Mesa R, Scott B, Buckley S, Roman-Torres K, Verstovsek S, Mascarenhas J. Pacritinib demonstrates spleen volume reduction in patients with myelofibrosis independent of JAK2V617F allele burden. Blood Adv. 2020 Dec 8;4(23):5929-5935. doi: 10.1182/bloodadvances.2020002970.

intervention_type: Drug

status: Terminated

lead_sponsor: CTI BioPharma

location_country:
United States
Netherlands
Germany
France
Czechia
Hungary
Belgium
Australia
New Zealand
Russian Federation
Canada
United Kingdom

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

location_facility: George Washington University- Medical Faculty Associates

location_facility: SCRI - Florida Cancer Specialists North Region

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Klinik I fur Innere Medizin, Universitat Koln

location_facility: Auckland District Health Board, Auckland City Hospital

location_facility: Washington University School of Medicine Division of Oncology

location_facility: Haematology and Oncology Clinics of Australia

location_facility: University of Debrecen, Belgyogyaszati Intezet

location_facility: SCRI- Florida Cancer Specialists South Region

location_facility: Military Medical Academy n.a. S.M. Kirov

location_facility: Russian Research Institute of Hematology and Transfusiology

location_facility: SZTE II. sz Belgyogyoszati Klinika es Kardiologiai Kozpont

location_facility: Texas Onocolgy-Baylor Sammons Cancer Center

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Investigative Clinical Research of Indiana

location_facility: Siouxland Hematology-Oncology Associates, L.L.P (SHOA)

location_facility: Hematology-Oncology Associates of Northern Jersey

source: euctr

title: A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

summary: Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

summary: This is a multi-center, randomized, double-blinded, placebo controlled trial.

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

family: Burris

full_name: Howard A. Burris

given: Howard A.

family: Chan

full_name: Arlene Chan

given: Arlene

family: Bardia

full_name: Aditya Bardia

given: Aditya

family: Thaddeus Beck

full_name: J. Thaddeus Beck

given: J.

family: Sohn

full_name: Joohyuk Sohn

given: Joohyuk

family: Neven

full_name: Patrick Neven

given: Patrick

family: Tripathy

full_name: Debu Tripathy

given: Debu

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Chia

full_name: Stephen Chia

given: Stephen

family: Esteva

full_name: Francisco J. Esteva

given: Francisco J.

family: Hart

full_name: Lowell Hart

given: Lowell

family: Zarate

full_name: Juan Pablo Zarate

given: Juan Pablo

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Lorenc

full_name: Karen Rodriguez Lorenc

given: Karen Rodriguez

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

journal_name: British Journal of Cancer

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Paré L, Martinez D, Chic N, Martínez-Sáez O, Brasó-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum in: J Clin Oncol. 2021 Nov 1;39(31):3525.

name: Department of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain

name: SOLTI Breast Cancer Research Group, Barcelona, Spain

name: Translational Genomics and Targeted Therapies in Solid Tumors, Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

name: Department of Medicine, University of Barcelona, Barcelona, Spain

name: Institute of Oncology (IOB) Quiron, Barcelona, Spain

family: Prat

full_name: Aleix Prat

given: Aleix

name: Novartis Institutes for BioMedical Research, Cambridge, MA

family: Chaudhury

full_name: Anwesha Chaudhury

given: Anwesha

family: Solovieff

full_name: Nadia Solovieff

given: Nadia

family: Paré

full_name: Laia Paré

given: Laia

family: Martinez

full_name: Débora Martinez

given: Débora

family: Chic

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

name: Department of Medical Oncology, Sarah Cannon Research Institute & Tennessee Oncology PLLC, Nashville, TN 37203, USA

ReferenceCitation: Hortobagyi GN. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. Breast Cancer Res. 2018 Oct 19;20(1):123. doi: 10.1186/s13058-018-1050-7.

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155. Erratum in: Ann Oncol. 2019 Nov 1;30(11):1842.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Janni W, Alba E, Bachelot T, Diab S, Gil-Gil M, Beck TJ, Ryvo L, Lopez R, Tsai M, Esteva FJ, Auñón PZ, Kral Z, Ward P, Richards P, Pluard TJ, Sutradhar S, Miller M, Campone M. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Jun;169(3):469-479. doi: 10.1007/s10549-017-4658-x. Epub 2018 Feb 5.

title: First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2− advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. Epub 2016 Oct 7. Erratum in: N Engl J Med. 2018 Dec 27;379(26):2582.

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Thailand
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Netherlands
Singapore
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Czechia
Israel
Spain
Turkey

location_facility: Georgia Cancer Specialists Georgia Cancer Spec

location_facility: UC Davis Comprehensive Cancer Center SC-2

location_facility: Virginia Cancer Specialists Fairfax Northern Virginia

location_facility: Virginia Piper Cancer Institute, Allina Health

location_facility: Richardson Hematology Oncology Associates

location_facility: Oncology Hematology Care Inc Oncology Hematology Care (3)

location_facility: NYU Langone Medical Center CV Research center SC-2

location_facility: University of Texas MD Anderson Cancer Center UT MDAnderson

location_facility: Utah Cancer Specialists Utah Cancer Specialists (11)

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: Dana Farber Cancer Institute Dana Farber-9

location_facility: Ingalls Memorial Hospital Ingalls Mem Hosp

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

location_facility: Vanderbilt University Medical Center SC-4

location_facility: Glendale-Adventist Medical Center Dept of Oncology

location_facility: City of Hope National Medical Center SC-5

location_facility: Saint Luke's Hospital/Marion Bloch Neuroscience Institute Oncology Dept

location_facility: University of Illinois Cancer Center at Chicago

location_facility: University of Colorado School of Medicine Onc Dept.

location_facility: The Angeles Clinic and Research Institute SC-3

location_facility: Mercy Clinic Oklahoma Communities Mercy Oncology

location_facility: Florida Cancer Research Institute Dept of Oncology

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med SC-3

location_facility: The Ohio State University Comprehensive Cancer Center Ohio State-2

location_facility: Northwest Medical Specialties Dept of Onc

location_facility: Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp. Onc Dept

location_facility: Cooper Cancer Center Cooper Cancer Center

location_facility: Rocky Mountain Cancer Centers RMCC - Aurora

location_facility: Penn State University Milton S Hershey Medical Center SC-3

location_facility: Center for Cancer and Blood Disorders SC

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: University of Texas Southwestern Medical Center


title: Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)

summary:
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need.

Primary objective:

To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection.

Secondary Objectives:

Efficacy:

To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days.
To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections.

Immunogenicity:

To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60.

Safety:

To describe the safety profile of all participants who received at least 1 injection.

primary_purpose: Prevention

ReferenceCitation: de Bruyn G, Gordon DL, Steiner T, Tambyah P, Cosgrove C, Martens M, Bassily E, Chan ES, Patel D, Chen J, Torre-Cisneros J, Fernando De Magalhães Francesconi C, Gesser R, Jeanfreau R, Launay O, Laot T, Morfin-Otero R, Oviedo-Orta E, Park YS, Piazza FM, Rehm C, Rivas E, Self S, Gurunathan S. Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2021 Feb;21(2):252-262. doi: 10.1016/S1473-3099(20)30331-5. Epub 2020 Sep 15.

family: de Bruyn

full_name: Guy de Bruyn

given: Guy

family: Gordon

full_name: David L Gordon

given: David L

family: Steiner

full_name: Theodore Steiner

given: Theodore

family: Tambyah

full_name: Paul Tambyah

given: Paul

family: Cosgrove

full_name: Catherine Cosgrove

given: Catherine

family: Martens

full_name: Mark Martens

given: Mark

family: Bassily

full_name: Ehab Bassily

given: Ehab

family: Chan

full_name: Eng-Soon Chan

given: Eng-Soon

family: Patel

full_name: Dhaval Patel

given: Dhaval

family: Chen

full_name: Josh Chen

given: Josh

family: Torre-Cisneros

full_name: Julian Torre-Cisneros

given: Julian

family: Fernando De Magalhães Francesconi

full_name: Carlos Fernando De Magalhães Francesconi

given: Carlos

family: Gesser

full_name: Richard Gesser

given: Richard

family: Jeanfreau

full_name: Robert Jeanfreau

given: Robert

family: Launay

full_name: Odile Launay

given: Odile

family: Laot

full_name: Thelma Laot

given: Thelma

family: Morfin-Otero

full_name: Rayo Morfin-Otero

given: Rayo

family: Oviedo-Orta

full_name: Ernesto Oviedo-Orta

given: Ernesto

family: Park

full_name: Yoon Soo Park

given: Yoon Soo

family: Piazza

full_name: Franco M Piazza

given: Franco M

family: Rehm

full_name: Christine Rehm

given: Christine

family: Rivas

full_name: Enrique Rivas

given: Enrique

family: Self

full_name: Steve Self

given: Steve

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available, Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

location_country:
Peru
Guatemala
Finland
Australia
Denmark
Taiwan
Costa Rica
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Japan
Panama
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Thailand
Canada
Korea, Republic of
Colombia
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Philippines
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location_facility:
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Investigational Site 006
Investigational Site 408
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Investigational Site 443
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Investigational Site 466
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title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure

acronym: COMMANDER HF

summary: The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.

ReferenceCitation: Ferreira JP, Cleland JG, Lam CSP, Anker SD, Mehra MR, van Veldhuisen DJ, Byra WM, La Police DA, Pitt B, Greenberg B, Zannad F. Heart failure re-hospitalizations and subsequent fatal events in coronary artery disease: insights from COMMANDER-HF, EPHESUS, and EXAMINE. Clin Res Cardiol. 2021 Oct;110(10):1554-1563. doi: 10.1007/s00392-021-01830-1. Epub 2021 Mar 8.

family: Ferreira

full_name: João Pedro Ferreira

given: João Pedro

family: Cleland

full_name: John G. Cleland

given: John G.

family: Lam

full_name: Carolyn S. P. Lam

given: Carolyn S. P.

family: Anker

full_name: Stefan D. Anker

given: Stefan D.

family: Mehra

full_name: Mandeep R. Mehra

given: Mandeep R.

family: van Veldhuisen

full_name: Dirk J. van Veldhuisen

given: Dirk J.

family: Byra

full_name: William M. Byra

given: William M.

family: La Police

full_name: David A. La Police

given: David A.

family: Pitt

full_name: Bertram Pitt

given: Bertram

family: Greenberg

full_name: Barry Greenberg

given: Barry

family: Zannad

full_name: Faiez Zannad

given: Faiez

journal_name: Clinical Research in Cardiology

oa_host_type: repository

license_normalized: no license

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

version: submittedVersion

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

ReferenceCitation: Ferreira JP, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, La Police DA, Anker SD, Mehra MR, Leroy C, Eschwege V, Toussaint-Hacquard M, Rossignol P, Greenberg B, Zannad F. Impact of Geographic Region on the COMMANDER-HF Trial. JACC Heart Fail. 2021 Mar;9(3):201-211. doi: 10.1016/j.jchf.2020.11.007. Epub 2021 Feb 3.

full_name: John G.F. Cleland

given: John G.F.

full_name: Carolyn S.P. Lam

given: Carolyn S.P.

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

ReferenceCitation: Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Mehra MR, Vaduganathan M, Fu M, Ferreira JP, Anker SD, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, Spiro TE, Deng H, Zannad F, Greenberg B. A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial. Eur Heart J. 2019 Nov 21;40(44):3593-3602. doi: 10.1093/eurheartj/ehz427.

name: Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

name: Janssen Research and Development, Spring House, PA, USA

name: Universite de Lorraine, INSERM Unite 1116, Vandoeuvre les Nancy, France

name: Clinical Investigation Center 1433, French Clinical Research Infrastructure Network, Investigation Network Initiative–Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Regional et Universitaire de Nancy, Vandoeuvre les Nancy, France

name: Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany

name: Robertson Centre for Biostatistics and Clinical Trials, University of Glasgow, Glasgow, Scotland

name: National Heart and Lung Institute, Imperial College London, London, England

name: National Heart Centre Singapore, Singapore

name: Duke-National University of Singapore, Singapore

name: The George Institute for Global Health, Australia

name: Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

name: Janssen Research and Development, Raritan, NJ, USA

name: Research and Development, Pharmaceuticals, Thrombosis and Hematology Therapeutic Area, Bayer US, LLC, Whippany, NJ, USA

name: Division of Cardiology, Department of Medicine, University of California, San Diego, La Jolla, CA, USA

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Greenberg B, Neaton JD, Anker SD, Byra WM, Cleland JGF, Deng H, Fu M, La Police DA, Lam CSP, Mehra MR, Nessel CC, Spiro TE, van Veldhuisen DJ, Vanden Boom CM, Zannad F. Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial. JAMA Cardiol. 2019 Jun 1;4(6):515-523. doi: 10.1001/jamacardio.2019.1049.

name: Cardiology Division, Department of Medicine, University of California, San Diego, La Jolla

name: Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis

name: Berlin–Brandenburg Center for Regenerative Therapies, Berlin, Germany

name: Department of Cardiology, German Center for Cardiovascular Research partner site Berlin, Charite Universitatsmedizin Berlin, Berlin, Germany

name: Janssen Research and Development, Raritan, New Jersey

name: Janssen Research and Development, Spring House, Pennsylvania

name: Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

name: Research and Development, Pharmaceuticals, Thrombosis and Hematology Therapeutic Area, Bayer US, Whippany, New Jersey

ReferenceCitation: Zannad F, Anker SD, Byra WM, Cleland JGF, Fu M, Gheorghiade M, Lam CSP, Mehra MR, Neaton JD, Nessel CC, Spiro TE, van Veldhuisen DJ, Greenberg B; COMMANDER HF Investigators. Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease. N Engl J Med. 2018 Oct 4;379(14):1332-1342. doi: 10.1056/NEJMoa1808848. Epub 2018 Aug 27.

name: From the Université de Lorraine, INSERM Unité 1116 and Clinical Investigation Center 1433, French Clinical Research Infrastructure Network, Investigation Network Initiative–Cardiovascular and Renal Clinical Trialists, Centre Hospitalier Régional et Universitaire de Nancy, Vandoeuvre lès Nancy, France (F.Z.); the Department of Cardiology and Berlin–Brandenburg Center for Regenerative Therapies, German Center for Cardiovascular Research partner site Berlin, Charité Universitätsmedizin Berlin, Berlin (S.D.A...

location_country:
Malaysia
Greece
Romania
Australia
Russian Federation
Denmark
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Brazil
Mexico
Czechia
Spain
Estonia
Latvia


lead_sponsor: Novartis Pharmaceuticals

primary_purpose: Other

location_country:
Italy
Austria
Sweden
Netherlands
Germany
France
Bulgaria
Greece
Japan
Poland
Hungary
Argentina
Belgium
Ireland
Spain
Denmark
United States
United Kingdom
Colombia

acronym: ENESTfreedom

location_facility: Oregon Health and Science University SC-6

location_facility: H Lee Moffitt Cancer Center and Research Institute SC - 5

location_facility: Sarah Cannon Research Institute Sarah Cannon Research

location_facility: Cancer Centers of the Carolinas Cancer Centers of Carolinas (3

ipd_sharing: Yes

title: A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease (MRD) Status on First Line Nilotinib Treatment.

summary: The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment

status_simplified: Ongoing


title: A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 Plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral Regimen of GSK1265744 Plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects

summary:
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278.

The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.

The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.

ReferenceCitation: Kerrigan D, Mantsios A, Gorgolas M, Montes ML, Pulido F, Brinson C, deVente J, Richmond GJ, Beckham SW, Hammond P, Margolis D, Murray M. Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a Phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018 Jan 5;13(1):e0190487. doi: 10.1371/journal.pone.0190487. eCollection 2018.

ReferenceCitation: Smith GHR, Henry WK, Podzamczer D, Masiá MDM, Bettacchi CJ, Arasteh K, Jaeger H, Khuong-Josses MA, Montes-Ramírez ML, Stellbrink HJ, Yazdanpanah Y, Richmond GJ, Sutton KC, Zhang F, McCoig CC, St Clair MH, Vandermeulen K, Van Solingen-Ristea R, Smith KY, Margolis DA, Spreen WR. Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. Open Forum Infect Dis. 2021 Aug 25;8(9):ofab439. doi: 10.1093/ofid/ofab439. eCollection 2021 Sep.

name: Maple Leaf Research, Toronto, ON, Canada

family: Smith

full_name: Graham H R Smith

given: Graham H R

name: Department of Medicine, Hennepin County Medical Center, Minneapolis, MN, USA

family: Henry

full_name: W Keith Henry

given: W Keith

name: HIV Unit, Department of Infectious Diseases, Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

name: Infectious Diseases Unit, Hospital General Universitario de Elche, Elche, Spain

family: Masiá

full_name: Maria Del Mar Masiá

given: Maria Del Mar

name: North Texas Infectious Disease Consultants, Dallas, TX, USA

family: Bettacchi

full_name: Christopher J Bettacchi

given: Christopher J

family: Arasteh

full_name: Keikawus Arasteh

given: Keikawus

name: MVZ Karlsplatz, HIV Research and Clinical Care Centre, Munich, Germany

family: Jaeger

full_name: Hans Jaeger

given: Hans

name: Service Maladies Infectieuses, CHG - Hôpital Delafontaine, Saint Denis, France

family: Khuong-Josses

full_name: Marie-Aude Khuong-Josses

given: Marie-Aude

name: HIV Unit, Service of Internal Medicine, Hospital La Paz Institute for Health Research, Madrid, Spain

family: Montes-Ramírez

full_name: Maria Luisa Montes-Ramírez

given: Maria Luisa

family: Stellbrink

full_name: Hans-Jürgen Stellbrink

given: Hans-Jürgen

name: Infectious Disease Department, Hôpital Bichat Claude Bernard, Paris, France

family: Yazdanpanah

full_name: Yazdan Yazdanpanah

given: Yazdan

name: Gary J. Richmond, MD, PA, Fort Lauderdale, FL, USA

family: Richmond

full_name: Gary J Richmond

given: Gary J

name: ViiV Healthcare, Research Triangle Park, NC, USA (KCS and DAM, Clinical Development; MHSC, Department of Translational Medical Research; KYS, Global Research and Medical Strategy; WRS, Medicines Development)

family: Sutton

full_name: Kenneth C Sutton

given: Kenneth C

name: Dev Biostatistics, GlaxoSmithKline, Collegeville, PA, USA

family: Zhang

full_name: Feifan Zhang

given: Feifan

name: Clinical Development, ViiV Healthcare, Tres Cantos, Spain

family: McCoig

full_name: Cynthia C McCoig

given: Cynthia C

family: St Clair

full_name: Marty H St Clair

given: Marty H

name: Medical Department of Infectious Diseases Therapeutic Area, Janssen Research and Development, Beerse, Belgium

family: Vandermeulen

full_name: Kati Vandermeulen

given: Kati

family: Van Solingen-Ristea

full_name: Rodica Van Solingen-Ristea

given: Rodica

full_name: Kimberly Y Smith

given: Kimberly Y

family: Margolis

full_name: David A Margolis

given: David A

family: Spreen

full_name: William R Spreen

given: William R

currency_apc_doaj: USD

journal_name: Open Forum Infectious Diseases

title: Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With HIV-1 Infection: ~5-Year Results From the LATTE-2 Study

ReferenceCitation: Letendre SL, Mills A, Hagins D, Swindells S, Felizarta F, Devente J, Bettacchi C, Lou Y, Ford S, Sutton K, Shaik JS, Crauwels H, D'Amico R, Patel P. Pharmacokinetics and antiviral activity of cabotegravir and rilpivirine in cerebrospinal fluid following long-acting injectable administration in HIV-infected adults. J Antimicrob Chemother. 2020 Mar 1;75(3):648-655. doi: 10.1093/jac/dkz504.

name: University of California San Diego, San Diego, CA, USA

name: Men’s Health Foundation, Los Angeles, CA, USA

name: Chatham County Health Dept, Savannah, GA, USA

name: University of Nebraska Medical Center, Omaha, NE, USA

name: Office of Franco Felizarta, MD, Bakersfield, CA, USA

name: Long Beach Education and Research Consultants, Long Beach, CA, USA

name: North Texas Infectious Diseases Consultants, P.A., Dallas, TX, USA

name: GlaxoSmithKline, Research Triangle Park, NC, USA

ReferenceCitation: Murray M, Pulido F, Mills A, Ramgopal M, LeBlanc R, Jaeger H, Canon V, Dorey D, Griffith S, Mrus J, Spreen W, Margolis D. Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study. HIV Res Clin Pract. 2019 Aug - Oct;20(4-5):111-122. doi: 10.1080/25787489.2019.1661696. Epub 2019 Sep 18.

name: Hospital Universitario 12 de Octubre, UCM, (imas12), Madrid, Spain;

name: Southern California Men’s Medical Group, West Hollywood, CA, USA;

name: Midway Immunology and Research Center, Fort Pierce, FL, USA;

name: Immunodeficiency Service Division of Hematology, Royal Victoria Hospital, McGill University Health Centre, Montreal, Quebec, Canada;

name: HIV Research and Clinical Care Centre, MUC Research GmbH and MVZ Karlsplatz, Munich, Germany;

name: Division of Janssen Pharmaceutica NV, Janssen Research & Development, Beerse, Belgium;

name: GlaxoSmithKline, Mississauga, Ontario, Canada;

ReferenceCitation: Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, Lutz T, Angel JB, Richmond GJ, Clotet B, Gutierrez F, Sloan L, Clair MS, Murray M, Ford SL, Mrus J, Patel P, Crauwels H, Griffith SK, Sutton KC, Dorey D, Smith KY, Williams PE, Spreen WR. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017 Sep 23;390(10101):1499-1510. doi: 10.1016/S0140-6736(17)31917-7. Epub 2017 Jul 24.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

location_country:
United States
France
Spain
Germany
Canada


title: A Multicenter Single-arm Extension Study to Describe the Long-term Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

lead_sponsor: Amgen

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
France
Poland
Lithuania
Canada
Sweden
Switzerland
Netherlands
Hungary
Portugal
United States
Germany
Italy
Austria
Czechia
Israel
New Zealand
Spain
Turkey
Latvia

status_simplified: Completed


title: Stryker Neurovascular Trevo® Retriever Registry

summary: The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Nogueira RG, Haussen DC, Liebeskind D, Jovin TG, Gupta R, Jadhav A, Budzik RF, Baxter B, Krajina A, Bonafe A, Malek A, Narata AP, Shields R, Zhang Y, Morgan P, Bartolini B, English J, Frankel MR, Veznedaroglu E; Trevo Registry and DAWN Trial Investigators. Stroke Imaging Selection Modality and Endovascular Therapy Outcomes in the Early and Extended Time Windows. Stroke. 2021 Jan;52(2):491-497. doi: 10.1161/STROKEAHA.120.031685. Epub 2021 Jan 12.

name: Department of Neurology, Emory University School of Medicine, Marcus Stroke & Neuroscience Center, Grady Memorial Hospital, Atlanta, GA (R.G.N., D.C.H., M.R.F.).

family: Nogueira

full_name: Raul G. Nogueira

given: Raul G.

family: Haussen

full_name: Diogo C. Haussen

given: Diogo C.

name: Department of Neurology, UCLA, Los Angeles, CA (D.L.).

family: Liebeskind

full_name: David Liebeskind

given: David

name: Department of Neurology, Cooper University Hospital Neurological Institute, Camden, NJ (T.G.J.).

family: Jovin

full_name: Tudor G. Jovin

given: Tudor G.

name: Department of Neurosciences, Wellstar Health System, Atlanta, GA (R.G.).

family: Gupta

full_name: Rishi Gupta

given: Rishi

name: Department of Neurology, Stroke Institute, University of Pittsburgh Medical Center, PA (A.J.).

family: Jadhav

full_name: Ashutov Jadhav

given: Ashutov

name: Department of Interventional Neuroradiology, Riverside Methodist Hospital/Ohio Health Research Institute, Columbus (R.F.B.).

family: Budzik

full_name: Ron F. Budzik

given: Ron F.

name: Department of Radiology, Erlanger Hospital, Chattanooga, TN (B. Baxter).

family: Baxter

full_name: Blaise Baxter

given: Blaise

name: Department of Radiology, University Hospital Hradec Kralove, Czech Republic (A.K.).

family: Krajina

full_name: Antonin Krajina

given: Antonin

name: Department of Neuroradiology, CHU Montpellier, France (A.B.).

family: Bonafe

full_name: Alain Bonafe

given: Alain

name: St. Mary’s Medical Center, West Palm Beach, FL (A.M.).

family: Malek

full_name: Ali Malek

given: Ali

name: Department of Neuroradiology, CHU Tours, France (A.P.N.).

family: Narata

full_name: Ana Paula Narata

given: Ana Paula

name: Stryker Neurovascular, Fremont, CA (R.S., Y.Z., P.M.).

family: Shields

full_name: Ryan Shields

given: Ryan

full_name: Yanchang Zhang

given: Yanchang

family: Morgan

full_name: Patricia Morgan

given: Patricia

name: Department of Interventional Radiology, La Pitie Salpetriere, Paris, France (B. Bartolini).

family: Bartolini

full_name: Bruno Bartolini

given: Bruno

name: Department of Neurology, California Pacific Medical Center, San Francisco (J.E.).

family: English

full_name: Joey English

given: Joey

family: Frankel

full_name: Michael R. Frankel

given: Michael R.

name: Department of Neurosciences, Drexel Neurosciences Institute, Philadelphia, PA (E.V.).

family: Veznedaroglu

full_name: Erol Veznedaroglu

given: Erol

name: for the Trevo Registry and DAWN Trial Investigators

journal_name: Stroke

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: Stryker Neurovascular

location_country:
Italy
United States
Switzerland
France
Czechia
Korea, Republic of
Thailand
Singapore
Hungary
Spain
Germany
Canada

location_facility: St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)

location_facility: La Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Riverside Methodist Hospital/ Ohio Health Research Institute

location_facility: Center for Advanced Research Excellence (St. Mary's Medical Center)

location_facility: Yale University / Yale-New Haven Hospital

location_facility: Good Samaritan Hospital Regional Medical Center

location_facility: Seoul National University Bundang Hospital

location_facility: National Institute of Clinical Neurosciences

location_facility: Methodist Healthcare - Memphis Hospitals

location_facility: Peoria Radiology Research & Education Foundation

location_facility: University of Tennessee Medical Center Knoxville

location_facility: Oregon Stroke Center, Oregon Health & Science University (OHSU)

location_facility: Emory University at Grady Memorial Hospital

location_facility: Hospital Universitario Central De Asturias

location_facility: California Pacific Medical Center (CPMC)


ReferenceCitation: Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. doi: 10.1016/S1470-2045(17)30180-8. Epub 2017 Mar 9.

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Ascierto

full_name: Paolo A Ascierto

given: Paolo A

family: Arance

full_name: Ana Arance

given: Ana

family: Dutriaux

full_name: Caroline Dutriaux

given: Caroline

family: Di Giacomo

full_name: Anna Maria Di Giacomo

given: Anna Maria

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Del Vecchio

full_name: Michele Del Vecchio

given: Michele

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Mandala

full_name: Mario Mandala

given: Mario

family: Thomas

full_name: Luc Thomas

given: Luc

family: Demidov

full_name: Lev Demidov

given: Lev

family: Garbe

full_name: Claus Garbe

given: Claus

family: Hogg

full_name: David Hogg

given: David

family: Liszkay

full_name: Gabriella Liszkay

given: Gabriella

family: Queirolo

full_name: Paola Queirolo

given: Paola

family: Wasserman

full_name: Ernesto Wasserman

given: Ernesto

family: Ford

full_name: James Ford

given: James

family: Weill

full_name: Marine Weill

given: Marine

family: Sirulnik

full_name: L Andres Sirulnik

given: L Andres

family: Jehl

full_name: Valentine Jehl

given: Valentine

family: Bozón

full_name: Viviana Bozón

given: Viviana

family: Long

full_name: Georgina V Long

given: Georgina V

family: Flaherty

full_name: Keith Flaherty

given: Keith

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Greece
Australia
Belgium
Russian Federation
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey

location_facility: Harry and Jeannette Weinberg Cancer Institute @Franklin Square

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: St. Luke's Cancer Center - Anderson Campus

location_facility: Medizinische Hochschule Hannover (Hannover Medical School)

location_facility: Karmanos Cancer Institute of Farmington Hills

location_facility: Azienza Ospedaliera Universitaria Senese

location_facility: Radboud University Nijmegen Medical Centre

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: The Ohio State University James Cancer Hospital

location_facility: The Ohio State University Martha Morehouse Medical Plaza

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Alberta Health Services - Cross Cancer Institute

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: Centro de Investigación Clínica ? Clínica Viedma

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Adana Ba?kent Hastanesi K??la Yerle?kesi

location_facility: St James s Institute of Clinical Oncology

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Istituto Dermopatico dell'Immacolata IRCCS

location_facility: Institut für Diagnostische und Interventionelle Radiologie Frankfurt

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro

location_facility: Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH

location_facility: Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: UT Southwestern University Hospital - Zale Lipshy

location_facility: Centre Hospitalier Universitaire Ambroise Pare

location_facility: Baskent University Medical Faculty Ankara Hospital

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Centre Hospitalier Universitaire Hopitaux de Rouen

location_facility: Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital Regional Universitario de Malaga Hospital General

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

location_facility: Kaiser Permanente Northwest Region Oncology/Hematology

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

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: Cancer Center Associates - Medical Oncology

location_facility: McGill University Health Center / Royal Victoria Hospital

location_facility: UT Southwestern University Hospital- St. Paul

location_facility: IRCCS Az. Osp. Universitaria San Martino- IST

location_facility: St. Luke's Cancer Center - Allentown Campus

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

location_facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

location_facility: St. Luke's University Hospital - Bethlehem Campus

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

title: The NEMO Trial (NRAS Melanoma and MEK Inhibitor):A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma

summary: Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival


ReferenceCitation: Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sørensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15.

family: Scagliotti

full_name: Giorgio V Scagliotti

given: Giorgio V

family: Gaafar

full_name: Rabab Gaafar

given: Rabab

family: Nowak

full_name: Anna K Nowak

given: Anna K

family: Nakano

full_name: Takashi Nakano

given: Takashi

family: van Meerbeeck

full_name: Jan van Meerbeeck

given: Jan

family: Popat

full_name: Sanjay Popat

given: Sanjay

family: Vogelzang

full_name: Nicholas J Vogelzang

given: Nicholas J

family: Grosso

full_name: Federica Grosso

given: Federica

family: Aboelhassan

full_name: Rasha Aboelhassan

given: Rasha

family: Jakopovic

full_name: Marko Jakopovic

given: Marko

family: Ceresoli

full_name: Giovanni L Ceresoli

given: Giovanni L

family: Taylor

full_name: Paul Taylor

given: Paul

family: Orlandi

full_name: Francisco Orlandi

given: Francisco

family: Fennell

full_name: Dean A Fennell

given: Dean A

family: Novello

full_name: Silvia Novello

given: Silvia

family: Scherpereel

full_name: Arnaud Scherpereel

given: Arnaud

family: Kuribayashi

full_name: Kozo Kuribayashi

given: Kozo

family: Cedres

full_name: Susana Cedres

given: Susana

family: Sørensen

full_name: Jens Benn Sørensen

given: Jens Benn

family: Pavlakis

full_name: Nick Pavlakis

given: Nick

family: Reck

full_name: Martin Reck

given: Martin

family: Velema

full_name: Derek Velema

given: Derek

family: von Wangenheim

full_name: Ute von Wangenheim

given: Ute

family: Kim

full_name: Miyoung Kim

given: Miyoung

family: Barrueco

full_name: José Barrueco

given: José

location_country:
Australia
Belgium
Russian Federation
Denmark
Croatia
France
Japan
Poland
Norway
Argentina
Canada
South Africa
Chile
Sweden
Netherlands
Portugal
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Egypt
Spain
Turkey

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: University Clinic for Pulmonary Diseases

location_facility: University Hospital of Occupational and Environmental Health

location_facility: Onco.Cent. - Instit. of Maria Sklodowskiej-Curie

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: St. Olavs Hospital, Universitetssykehuset i Trondheim

location_facility: Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: National Cancer Institute, Cairo University

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

location_facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: Japan Labour Health and Safety Organization Okayama Rosai Hospital

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: Rigshospitalet, København, Onkologisk afdeling

location_facility: Centro Internacional de Estudios Clínicos - CIEC

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

title: LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma

summary: This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.


title: A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism

summary: The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

ReferenceCitation: Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13. Review.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

location_country:
Greece
Belgium
Russian Federation
Denmark
France
Poland
Lithuania
Canada
Turkey
Sweden
Switzerland
Hungary
Portugal
United States
Germany
Italy
Austria
Czechia
New Zealand
Spain
Estonia
Latvia