acronym: CANDOR

title: A Randomized, Open-label, Phase 3 Study Comparing Carfilzomib, Dexamethasone, and Daratumumab to Carfilzomib and Dexamethasone for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

ReferenceCitation: Quach H, Nooka A, Samoylova O, Venner CP, Kim K, Facon T, Spencer A, Usmani SZ, Grosicki S, Suzuki K, Delimpasi S, Weisel K, Obreja M, Zahlten-Kumeli A, Mateos MV. Carfilzomib, dexamethasone and daratumumab in relapsed or refractory multiple myeloma: results of the phase III study CANDOR by prior lines of therapy. Br J Haematol. 2021 Aug;194(4):784-788. doi: 10.1111/bjh.17541. Epub 2021 May 28.

ReferenceCitation: Siegel D, Weisel K, Zahlten-Kumeli A, Medhekar R, Ding B, Leleu X. Health-related quality of life outcomes from the CANDOR study in patients with relapsed or refractory multiple myeloma. Leuk Lymphoma. 2021 Dec;62(12):3002-3010. doi: 10.1080/10428194.2021.1941927. Epub 2021 Jun 26.

ReferenceCitation: Suzuki K, Min CK, Kim K, Lee JJ, Shibayama H, Ko PS, Huang SY, Li SS, Ding B, Khurana M, Iida S. Carfilzomib, dexamethasone, and daratumumab in Asian patients with relapsed or refractory multiple myeloma: post hoc subgroup analysis of the phase 3 CANDOR trial. Int J Hematol. 2021 Dec;114(6):653-663. doi: 10.1007/s12185-021-03204-9. Epub 2021 Aug 19.

ReferenceCitation: Usmani SZ, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Gavriatopoulou M, Oriol A, Rabin N, Nooka A, Qi M, Beksac M, Jakubowiak A, Ding B, Zahlten-Kumeli A, Yusuf A, Dimopoulos M. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): updated outcomes from a randomised, multicentre, open-label, phase 3 study. Lancet Oncol. 2022 Jan;23(1):65-76. doi: 10.1016/S1470-2045(21)00579-9. Epub 2021 Dec 3.

ReferenceCitation: Landgren O, Weisel K, Rosinol L, Touzeau C, Turgut M, Hajek R, Mollee P, Kim JS, Shu N, Hu X, Li C, Usmani SZ. Subgroup analysis based on cytogenetic risk in patients with relapsed or refractory multiple myeloma in the CANDOR study. Br J Haematol. 2022 Sep;198(6):988-993. doi: 10.1111/bjh.18233. Epub 2022 May 24.

ReferenceCitation: Leleu X, Beksac M, Chou T, Dimopoulos M, Yoon SS, Prince HM, Pour L, Shelekhova T, Chari A, Khurana M, Zhang J, Obreja M, Qi M, Oriol A, Siegel D. Efficacy and safety of weekly carfilzomib (70 mg/m(2)), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option: a cross-study comparison of the CANDOR and EQUULEUS studies. Leuk Lymphoma. 2021 Feb;62(2):358-367. doi: 10.1080/10428194.2020.1832672. Epub 2020 Oct 28.

ReferenceCitation: Dimopoulos M, Quach H, Mateos MV, Landgren O, Leleu X, Siegel D, Weisel K, Yang H, Klippel Z, Zahlten-Kumeli A, Usmani SZ. Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study. Lancet. 2020 Jul 18;396(10245):186-197. doi: 10.1016/S0140-6736(20)30734-0. Erratum in: Lancet. 2020 Aug 15;396(10249):466.

location_country:
Poland
Taiwan
Romania
Spain
Greece
Austria
Australia
Russian Federation
Canada
United Kingdom
Hungary
Korea, Republic of
United States
France
Turkey
Belgium
Japan
Bulgaria
Czechia

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich w Chorzowie

location_facility: Lynn Cancer Center Boca Raton Regional Hospital, Lynn Cancer Institute

location_facility: Emory University Winship Cancer Institute

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: New York Presbyterian Hospital, Weill Cornell Medical College

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Fort Wayne Medical Oncology and Hematology

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

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Centre Hospitalier DÃ©partemental les Oudairies

location_facility: University of Chicago Medical Center - Multiple Myeloma Research Consortium

location_facility: Clinic of professional pathology and hematology

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Barwon Health, University Hospital Geelong

location_facility: Profesor Dr Ion Chiricuta Institut of Oncology

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Centre Hospitalier RÃ©gional Universitaire de Lille - HÃ´pital Claude Huriez

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Cancer Institute Hospital of Japanese Foundation for Cancer Research

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

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: SBHI of Nizhny Novgorod region Regional Clinical Hospital of Nizhny Novgorod na N A Semashko

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar

location_facility: Baylor Charles A Sammons Cancer Center at Dallas

location_facility: Bekes Megyei Kozponti Korhaz Dr Rethy Pal Tagkorhaz

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Centrum Onkologii Ziemi Lubelskiej im Swietego Jana z Dukli

location_facility: Severance Hospital Yonsei University Health System

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

summary: Compare carfizomib, dexamethasone, and daratumumab (KdD) to Carfilzomib and dexamethasone (Kd) in terms of progression free survival (PFS) in participants with multiple myeloma who have relapsed after 1 to 3 prior therapies.


ipd_sharing: Yes

status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Drug

title: TALAPRO-1: A PHASE 2, OPEN-LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE-BASED CHEMOTHERAPY AND PROGRESSED ON AT LEAST 1 NOVEL HORMONAL AGENT (ENZALUTAMIDE AND/OR ABIRATERONE ACETATE/PREDNISONE)

study_completion_date_type: Anticipated

lead_sponsor: Pfizer

type: Other Identifier

type: EudraCT Number

source: euctr

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Mehra N, Fizazi K, de Bono JS, Barthélémy P, Dorff T, Stirling A, Machiels JP, Bimbatti D, Kilari D, Dumez H, Buttigliero C, van Oort IM, Castro E, Chen HC, Di Santo N, DeAnnuntis L, Healy CG, Scagliotti GV. Talazoparib, a Poly(ADP-ribose) Polymerase Inhibitor, for Metastatic Castration-resistant Prostate Cancer and DNA Damage Response Alterations: TALAPRO-1 Safety Analyses. Oncologist. 2022 Oct 1;27(10):e783-e795. doi: 10.1093/oncolo/oyac172.

ReferenceCitation: de Bono JS, Mehra N, Scagliotti GV, Castro E, Dorff T, Stirling A, Stenzl A, Fleming MT, Higano CS, Saad F, Buttigliero C, van Oort IM, Laird AD, Mata M, Chen HC, Healy CG, Czibere A, Fizazi K. Talazoparib monotherapy in metastatic castration-resistant prostate cancer with DNA repair alterations (TALAPRO-1): an open-label, phase 2 trial. Lancet Oncol. 2021 Sep;22(9):1250-1264. doi: 10.1016/S1470-2045(21)00376-4. Epub 2021 Aug 10. Erratum in: Lancet Oncol. 2022 May;23(5):e207. Lancet Oncol. 2022 Jun;23(6):e249.

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.

enrollment_type: Actual

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
Netherlands
United Kingdom
Hungary
Korea, Republic of
United States
France
Belgium
Germany

location_facility: The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust , Sycamore House

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Departemental Les Oudairies

location_facility: Institut de Cancerologie Strasbourg Europe

location_facility: IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1

location_facility: Olivia Newton John Cancer Wellness & Research Centre Austin Health

location_facility: Azienda Ospedaliero-Universitaria S. Luigi Gonzaga-SCDU Oncologia Medica

location_facility: Weill Cornell Medical Center-New York Presbyterian Hospital

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: Orszagos Onkologiai Intezet, "C" Belgyogyaszati-Onkologiai es Klinikai Farmakogogiai Osztaly

location_facility: Medical Imaging St Vincent's Hospital Sydney

location_facility: SD Oncologia Clinica Sperimentale di Uro-Ginecologia

location_facility: AULSS3 Serenissima - Ospedale dell'Angelo - Oncologia Medica

location_facility: Swedish Cancer Institute Issaquah Campus

location_facility: Clinica Universidad de Navarra-Oncology Service

location_facility: Hospital Universitario Quironsalud Madrid-Oncology Service

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Azienda Ospedaliero Universitari di Parma - U.O. Oncologia Medica

location_facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital de Clinicas de Porto Alegre-HCPA

location_facility: Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

location_facility: The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center

location_facility: Azienda Ospedaliero Universitaria di Parma - U.O. Oncologia Medica

location_facility: Azienda Ospedaliera San Camillo Forlanini

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

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Socio Sanitaria Territoriale di Cremona (Istituti Ospitalieri di Cremona)

location_facility: Medizinische Fakultat Mannheim der Universitat Heidelberg

location_facility: Clinique Victor Hugo-Centre Jean Bernard

location_facility: University of California, Irvine Medical Center

location_facility: Ordensklinikum Linz, Barmherzige Schwestern

location_facility: Intergrated Clinical Oncology Network (ICON)

location_facility: Szabolcs- Szatmar-Bereg Megyei Korhazak es Egyetemi Oktato Korhaz

location_facility: Seoul National University Bundang Hospital

location_facility: Froedtert Hospital/Medical College of Wisconsin

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Weill Cornell Medical Center - New York Presbyterian Hospital

location_facility: Hospital General Vall D'Hebron-Oncology Service

location_facility: St Vincent's Hospital Sydney, The Kinghorn Cancer Centre

location_facility: Instituto Valenciano de Oncologia (IVO-FINCIVO)

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Fundacao Pio XII-Hospital de Cancer de Barretos

location_facility: Sharp Outpatient Infusion Therapy Center

location_facility: UC Irvine Health Investigational Drug Pharmacy

summary: The purpose of this international, phase 2, open-label, response rate study of talazoparib is to assess the efficacy and safety of talazoparib in men with DNA repair defects metastatic castration-resistant prostate cancer (CRPC) who previously received taxane-based chemotherapy and progressed on at least 1 novel hormonal agent (enzalutamide and/or abiraterone acetate/prednisone).

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor (CITADEL-204)

summary: The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL) who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Incyte Corporation

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Australia
Argentina
United States
France
Israel
Belgium
Germany

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: University of Miami Sylvester Comprehensive Cancer Center

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Hematology Oncology Associates of Rockland

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Boca Raton Clinical Research Medical Inc.

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Azienda Ospedaliera San Gerardo Di Monza

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Kent Oncology Centre - Maidstone Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti "Villa Sofia - Cervello"

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

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

location_facility: Szpitale Wojew�Dzkie W Gdyni Sp�?Ka Z Ograniczon? Odpowiedzialno?Ci?

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Ospedale Delle Croci - Ematologia Ravenna

location_facility: University of Alabama At Birmingham Comprehensive Cancer Center

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Charleston Hematology Oncology Associates Pa

location_facility: St. Mary'S Hospital Regional Cancer Center

location_facility: Klinika Transplantacji Komorel Krwiotworczych

location_facility: COMPREHENSIVE CANCER CeNTERS OF NEVADA - TWAIN

location_facility: Rush University Medical Center - Consultants in Hematology

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: University of Bologna, Institute of Haematology �L. E A. Ser�Gnoli�


title: GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease

summary: The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

ReferenceCitation: Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.

ReferenceCitation: Zeiser R, Socié G, Schroeder MA, Abhyankar S, Vaz CP, Kwon M, Clausen J, Volodin L, Giebel S, Chacon MJ, Meyers G, Ghosh M, Deeren D, Sanz J, Morariu-Zamfir R, Arbushites M, Lakshminarayanan M, Barbour AM, Chen YB. Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301): a randomised, multicentre, double-blind, phase 3 trial. Lancet Haematol. 2022 Jan;9(1):e14-e25. doi: 10.1016/S2352-3026(21)00367-7.

location_country:
Poland
Taiwan
Portugal
Spain
Greece
Austria
Australia
Italy
Finland
New Zealand
Switzerland
United Kingdom
Korea, Republic of
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Universitatsklinikum Hamburg - Eppendorf

location_facility: Washington University School of Medicine

location_facility: University Clinic Carl Gustav Carus, Technical University Dresden

location_facility: John Theurer Cancer Center At Hackensack UMC

location_facility: SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine

location_facility: Universitatsklinikum Freiburg - Klinik fur Innere Medizin I

location_facility: Centro Hospitalar Lisboa Norte - Hospital de Santa Maria

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia

location_facility: Hopital Haut Leveque - CHU Bordeaux - Maladies du sang

location_facility: Sarah Cannon Research Institute, LLC (SCRI)

location_facility: Oregon Health & Science University (OHSU)

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Universitaetsspital Zuerich - Klinik fuer Haematology

location_facility: Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University of Oklahoma - Health Sciences Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Hospital Universitario Marques de Valdecilla

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

location_facility: Hadassah Hebrew University Medical Center Ein Karem

location_facility: University of California, San Diego (UCSD) - Moores Cancer Center

location_facility: General Hospital of Thessaloniki G. Papanikolaou - Hematology Department

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

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

location_facility: Advocate Lutheran General Hospital - Oncology Specialists SC

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: Hopital universitaire du Sart Tilman de Liege

location_facility: Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza

location_facility: University Hospitals Cleveland Medical Center

location_facility: C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: University of Mississippi Medical Center

location_facility: Universtity Hospital Basel - Haematology

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)

location_facility: Wake Forest Baptist Medical Center - Wake Forest University School of Medicine

location_facility: Indiana University (IU) Melvin and Bren Simon Cancer Center

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

location_facility: University of Colorado - Aurora Cancer Center

location_facility: University of Miami - Sylvester Cancer Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica

location_facility: Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals

location_facility: General Hospital Sint-Jan Brugge-Oostend

location_facility: Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)

location_facility: UHKT Prague - Institute of Hematology and Blood Transfusion

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Universitaetsmedizin der Johannes Gutenberg

location_facility: Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol

location_facility: University of Florida (UF) - Division of Hematology & Oncology

location_facility: UKGM Marburg Innere Medizin: Haematologie Onkolog

location_facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti

location_facility: Hospital Clinico de Santiago de Compostela

status_simplified: Completed


title: Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies

acronym: CheckMate 908

summary: The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Brazil
Hong Kong
Spain
United Kingdom
Russian Federation
Australia
Netherlands
Canada
Sweden
United States
France
Israel
Norway
Germany

location_facility: Cincinnati Children'S Hospital Medical Center

intervention_type: Biological


title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

acronym: e-NOBORI

summary:
Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.

Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.

Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

study_type: Observational

time_perspective: Prospective

ReferenceType: background

ReferenceCitation: Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6.

ReferenceCitation: Detre KM, Holmes DR Jr, Holubkov R, Cowley MJ, Bourassa MG, Faxon DP, Dorros GR, Bentivoglio LG, Kent KM, Myler RK. Incidence and consequences of periprocedural occlusion. The 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation. 1990 Sep;82(3):739-50.

ReferenceCitation: Holmes DR Jr, Holubkov R, Vlietstra RE, Kelsey SF, Reeder GS, Dorros G, Williams DO, Cowley MJ, Faxon DP, Kent KM, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. J Am Coll Cardiol. 1988 Nov;12(5):1149-55.

ReferenceCitation: Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501.

ReferenceCitation: Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95.

ReferenceCitation: Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80.

ReferenceCitation: Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schömig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabaté M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Jüni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. Review.

ReferenceCitation: Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23.

ReferenceCitation: Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation. 2004 Feb 10;109(5):634-40.

ReferenceCitation: Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003 Jan 7;107(1):38-42.

ReferenceCitation: Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34.

ReferenceCitation: Ostojic M, Sagic D, Beleslin B, Jung R, Perisic Z, Jagic N, Nedeljkovic M, Mangovski L, Milosavljevic B, Stojkovic S, Orlic D, Antonic Z, Miloradovic V, Topic D, Paunovic D. First clinical comparison of Nobori -Biolimus A9 eluting stents with Cypher- Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes. EuroIntervention. 2008 Mar;3(5):574-9.

ReferenceCitation: Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30.

ReferenceCitation: Chevalier B, Silber S, Park SJ, Garcia E, Schuler G, Suryapranata H, Koolen J, Hauptmann KE, Wijns W, Morice MC, Carrie D, van Es GA, Nagai H, Detiege D, Paunovic D, Serruys PW; NOBORI 1 Clinical Investigators. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberté paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase 2. Circ Cardiovasc Interv. 2009 Jun;2(3):188-95. doi: 10.1161/CIRCINTERVENTIONS.108.823443. Epub 2009 May 8.

ReferenceCitation: Jain AK, Meredith IT, Lotan C, Rothman MT, Pateraki S; E-Five Investigators. Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry. Am J Cardiol. 2007 Oct 22;100(8B):77M-83M.

ReferenceCitation: Urban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, Berge C, Deme M, Stoll HP; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation. 2006 Mar 21;113(11):1434-41. Epub 2006 Mar 13.

ReferenceCitation: Stone GW. SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus Eluting Stent and a Paclitaxel Eluting Stent in Patients With Coronary Artery Disease One Year Clinical Results. 2009.

ReferenceCitation: Grube E, Spirit V registry: one-year follow-up. EuroIntervention 2009; 5

ReferenceCitation: Turco MA, Ormiston JA, Popma JJ, Mandinov L, O'Shaughnessy CD, Mann T, McGarry TF, Wu CJ, Chan C, Webster MW, Hall JJ, Mishkel GJ, Cannon LA, Baim DS, Koglin J. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83. Epub 2007 Apr 6.

ReferenceCitation: Rodriguez-Granillo GA, Valgimigli M, Garcia-Garcia HM, Ong AT, Aoki J, van Mieghem CA, Tsuchida K, Sianos G, McFadden E, van der Giessen WJ, van Domburg R, de Feyter P, Serruys PW. One-year clinical outcome after coronary stenting of very small vessels using 2.25 mm sirolimus- and paclitaxel-eluting stents: a comparison between the RESEARCH and T-SEARCH registries. J Invasive Cardiol. 2005 Aug;17(8):409-12.

ReferenceCitation: Ong AT, van Domburg RT, Aoki J, Sonnenschein K, Lemos PA, Serruys PW. Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol. 2006 Apr 4;47(7):1356-60. Epub 2006 Mar 20.

ReferenceCitation: Galløe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamäki K, Junker A, Aarøe J, Abildgaard U, Ravkilde J, Engstrøm T, Jensen JS, Andersen HR, Bøtker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrøm SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.

ReferenceCitation: Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.

ReferenceCitation: Novack V, Cutlip D, Kleiman N, Pencina M, Mauri L, Yen CH, Berger P, Goldberg S, Kellett M, Waksman R, Hong M, Raizner AE, Cohen DJ. In-hospital and 1-year outcomes among unselected percutaneous coronary intervention patients treated with either sirolimus- or paclitaxel-eluting stents: results from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Aug;2(8):767-75. doi: 10.1016/j.jcin.2009.05.016.

ReferenceCitation: Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.

ReferenceCitation: Silber S, Albertsson P, Avilés FF, Camici PG, Colombo A, Hamm C, Jørgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. Epub 2005 Mar 15.

ReferenceCitation: Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.

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ReferenceCitation: Tillmanns H, Waas W, Voss R, Grempels E, Hölschermann H, Haberbosch W, Waldecker B. Gender differences in the outcome of cardiac interventions. Herz. 2005 Aug;30(5):375-89. Review. English, German.

ReferenceCitation: Berger JS, Elliott L, Gallup D, Roe M, Granger CB, Armstrong PW, Simes RJ, White HD, Van de Werf F, Topol EJ, Hochman JS, Newby LK, Harrington RA, Califf RM, Becker RC, Douglas PS. Sex differences in mortality following acute coronary syndromes. JAMA. 2009 Aug 26;302(8):874-82. doi: 10.1001/jama.2009.1227.

ReferenceCitation: Briguori C, Airoldi F, Chieffo A, Carlino M, Montorfano M, Colombo A. Renal function and drug-eluting stent. Int J Cardiol. 2010 Jun 25;142(1):92-4. doi: 10.1016/j.ijcard.2008.11.138. Epub 2009 Jan 15.

ReferenceCitation: Latif F, Kleiman NS, Cohen DJ, Pencina MJ, Yen CH, Cutlip DE, Moliterno DJ, Nassif D, Lopez JJ, Saucedo JF; EVENT Investigators. In-hospital and 1-year outcomes among percutaneous coronary intervention patients with chronic kidney disease in the era of drug-eluting stents: a report from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Jan;2(1):37-45. doi: 10.1016/j.jcin.2008.06.012.

ReferenceCitation: Rosenblum MA, Robbins MJ, Farkouh ME, Winston JA, Kim MC. Diminished benefits of drug-eluting stents versus bare metal stents in patients with severe renal insufficiency. Nephron Clin Pract. 2009;113(3):c198-202. doi: 10.1159/000232602. Epub 2009 Aug 12.

ReferenceCitation: Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schömig A; Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J. 2006 Feb;27(3):260-6. Epub 2006 Jan 9.

ReferenceCitation: Park SW, Lee CW, Hong MK, Kim JJ, Cho GY, Nah DY, Park SJ. Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries. Eur Heart J. 2000 Nov;21(21):1785-9.

ReferenceCitation: Ortolani P, Marzocchi A, Marrozzini C, Palmerini T, Saia F, Taglieri N, Aquilina M, Baldazzi F, Silenzi S, Cooke RM, Reggiani ML, Branzi A. Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization. Catheter Cardiovasc Interv. 2007 May 1;69(6):790-8.

ReferenceCitation: Tanimoto S, Daemen J, Serruys PW. Update on stents: recent studies on the TAXUS stent system in small vessels. Vasc Health Risk Manag. 2007;3(4):481-90. Review.

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ReferenceCitation: Stettler C, Allemann S, Egger M, Windecker S, Meier B, Diem P. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart. 2006 May;92(5):650-7. Epub 2005 Oct 26. Review.

ReferenceCitation: Boccara F, Teiger E, Cohen A. Role of drug eluting stents in diabetic patients. Heart. 2006 May;92(5):579-81. Epub 2006 Jan 31.

ReferenceCitation: Sukhija R, Mehta JL, Sachdeva R. Present status of coronary bifurcation stenting. Clin Cardiol. 2008 Feb;31(2):63-6. Review.

ReferenceCitation: Kim YH, Park SW, Lee SW, Park DW, Yun SC, Lee CW, Hong MK, Kim HS, Ko JK, Park JH, Lee JH, Choi SW, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Park SJ; Long-DES-II Study Investigators. Sirolimus-eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease. Circulation. 2006 Nov 14;114(20):2148-53. Epub 2006 Oct 23.

ReferenceCitation: Hannan EL, Wu C, Walford G, Culliford AT, Gold JP, Smith CR, Higgins RS, Carlson RE, Jones RH. Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease. N Engl J Med. 2008 Jan 24;358(4):331-41. doi: 10.1056/NEJMoa071804.

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ReferenceCitation: Lotan C, Almagor Y, Kuiper K, Suttorp MJ, Wijns W. Sirolimus-eluting stent in chronic total occlusion: the SICTO study. J Interv Cardiol. 2006 Aug;19(4):307-12.

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lead_sponsor: Terumo Europe N.V.

location_country:
Serbia
Spain
United Kingdom
Lithuania
Ukraine
Romania
Czechia
Poland
Slovenia
Austria
Russian Federation
Indonesia
Israel
Malta
Mexico
Sweden
Egypt
Brazil
Bangladesh
Hungary
Germany
Bulgaria
Denmark
Taiwan
Belarus
Ireland
Georgia
Estonia
Latvia
France
Chile
Netherlands

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Friedrichs

location_facility: Fundação Bahiana de Cardiologia (MC Oliveira Prest

location_facility: Hospital Beneficencia Portuguesa de Sao Paulo

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hôpital Europeen Georges Pompidou (HEGP)

location_facility: Academian E.N Meshalkin State Research Institute of circulation Pathology

location_facility: Military Hospital N3 named by Vishnevsky

location_facility: Southern Health and Social Care Trust Craigavon Ar

location_facility: Hospital Santa Isabel-Sociedade Divina Providência

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Humboldt

location_facility: Gottsegen National Cardiology Institute (GOKI)

location_facility: Institute for Cardiovascular Disease Dedinje

location_facility: Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital

location_facility: Republican Clinical Medical Center (Presidential Hospital)

location_facility: National Heart Foundation Hospital & Research Institute

location_facility: Szpital Klinicznk Przemienienia (University Hospital)

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Am Urban

location_facility: Real e Benemérita Assoção Portuguesa de Beneficênc

location_facility: Institut Hospitalier Jacques Cartier (ICPS Massy)

location_facility: Hospital of Lithuania University of Health Science

location_facility: Central Clinical Hospital N°2 Russia Railways

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Frimley Park Hospital NHS Foundation Trust

location_facility: Hospital Lomas de San Luis Internacional

location_facility: Instituto Nacional De Cardiologia "Ignacio Chávez"

location_facility: Republican Scientific and Practical Center of Cardiology

location_facility: Hospital Universitario Dr. José Eleuterio Gonzalez

location_facility: Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital

location_facility: Clinique de l'Europe à Amiens (SAS Cardio Amiens)

location_facility: Ev.Bethesda-Johanniter Klinikum Duisburg GmbH

location_facility: Uppsala Akademiska Sjukhus, Kardiologkliniken

location_facility: Instituto do Coração do Triângulo Mineiro

location_facility: Irmandade da Santa Casa de Misericórdia de Marília

location_facility: Hospital Ana Costa (ENDOCOR Serviços Médicos Ltda)

location_facility: Central Lasarettet i Västerås, Angio/PCI lab. Medi

location_facility: National Cardiovascular Center Harapan Kita

location_facility: State cardiovascular center based on regional clin

location_facility: Instituto Cardiovascular de Linhares (Unicor)

location_facility: Saratov Research Institute of science for cardiology

location_facility: National Institute of Cardiovascular Surgery AMS

location_facility: Uniklinik Schleswig-Holstein, Campus Kiel

location_facility: Evangelisch Freikirchliches Krankenhaus und Herzze

location_facility: V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca)

location_facility: Royal Blackpool hospital (Lancashire Heart Centre)

location_facility: Hospital Cruz Vermelha Brasileira Filial do Paraná

location_facility: Federal center of heart,blood and endocrinology diseases named by Almazov


title: A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment

summary: This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

ReferenceCitation: Vrdoljak E, Marschner N, Zielinski C, Gligorov J, Cortes J, Puglisi F, Aapro M, Fallowfield L, Fontana A, Inbar M, Kahan Z, Welt A, Lévy C, Brain E, Pivot X, Putzu C, González Martín A, de Ducla S, Easton V, von Minckwitz G. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer. Ann Oncol. 2016 Nov;27(11):2046-2052. Epub 2016 Aug 8.

ReferenceCitation: von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28.

lead_sponsor: Hoffmann-La Roche

location_country: Croatia Brazil Spain Greece Austria Italy Argentina Switzerland Hungary France Israel Germany Slovakia


acronym: ROSiA

title: Global Study to Assess the Addition of Bevacizumab to Carboplatin and Paclitaxel as Front-line Treatment of Epithelial Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma

ReferenceCitation: Oza AM, Selle F, Davidenko I, Korach J, Mendiola C, Pautier P, Chmielowska E, Bamias A, DeCensi A, Zvirbule Z, González-Martín A, Hegg R, Joly F, Zamagni C, Gadducci A, Martin N, Robb S, Colombo N. Efficacy and Safety of Bevacizumab-Containing Therapy in Newly Diagnosed Ovarian Cancer: ROSiA Single-Arm Phase 3B Study. Int J Gynecol Cancer. 2017 Jan;27(1):50-58. doi: 10.1097/IGC.0000000000000836.

location_country: Macedonia, The Former Yugoslav Republic of

summary: This open-label, non-comparative, multi-center study will assess the safety profile and efficacy of Avastin (bevacizumab) when added to carboplatin and paclitaxel therapy in participants with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Participants will receive 15 milligrams/kilogram (mg/kg) Avastin intravenously (IV) on Day 1 of every cycle for up to 36 cycles of 3 weeks each, carboplatin (area under the plasma concentration-time curve [AUC] 5-6 mg/ml/min) on Day 1 every 3 weeks for a maximum of 8 cycles and paclitaxel 175 milligram per square meter (mg/m^2) on Day 1 every 3 weeks or 80 mg/m^2 every week for a maximum of 8 cycles. The anticipated time on study drug will be 108 weeks or until disease progression or unacceptable toxicity.


title: A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Pazopanib as Adjuvant Therapy for Subjects With Localized or Locally Advanced RCC Following Nephrectomy

acronym: PROTECT

summary: This randomized Phase III study is to evaluate whether pazopanib compared with placebo can prevent or delay recurrence of kidney cancer in patients with moderately high or high risk of developing recurrence after undergoing kidney cancer surgery.

ReferenceCitation: Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. doi: 10.1200/JCO.2009.23.9764. Epub 2010 Jan 25.

ReferenceCitation: Motzer RJ, Russo P, Haas N, Doehn C, Donskov F, Gross-Goupil M, Varlamov S, Kopyltsov E, Lee JL, Lim HY, Melichar B, Zemanova M, Rini B, Choueiri TK, Wood L, Reaume MN, Stenzl A, Chowdhury S, McDermott R, Michael A, Izquierdo M, Aimone P, Zhang H, Sternberg CN; PROTECT study investigators. Adjuvant Pazopanib Versus Placebo After Nephrectomy in Patients With Localized or Locally Advanced Renal Cell Carcinoma: Final Overall Survival Analysis of the Phase 3 PROTECT Trial. Eur Urol. 2021 Mar;79(3):334-338. doi: 10.1016/j.eururo.2020.12.029. Epub 2021 Jan 15.

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Luxembourg
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Russian Federation
Argentina
Israel
Turkey
Slovakia
Brazil
Canada
Hungary
China
Germany
Denmark
Greece
Ireland
Korea, Republic of
France
Chile


title: A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist

summary: This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

lead_sponsor: Ferring Pharmaceuticals

location_country:
Denmark
Portugal
United Kingdom
Greece
Ireland
Italy
Netherlands
Finland
Switzerland
Hungary
France
Belgium
Norway
Germany
Slovakia

location_facility: Amalia Fleming General Hospital of Athens

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: General Hospital of Volos "Achillopouleio"

location_facility: "G. Gennimtas" General Hospital of Athens

location_facility: "Agios Savas" Anticancer-Oncology Hospital of Athens

location_facility: Istituto Nazionale Tumori "Regina Elena"

location_facility: Centre Hospitalier d'Athis Mons site Caron

location_facility: "G. Gennimtas" General Hospital of Thessaloniki

location_facility: Azienda Ospedaliera Universitaria OO.RR. S.Giovanni di Dio e Ruggi d'Aragona

location_facility: Olso Universitetssykehus HF, Radiumhospitalet

location_facility: Azienda Ospedaliera Mater Domini di Catanzaro

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: 2nd IKA-ETAM "Panagia" General Hospital of Thessaloniki

location_facility: Azienda Sanitaria Regionale del Molise (ASREM)

location_facility: Gemeinschaftspraxis Dres Effert und Benedic

location_facility: Helse Nordmore og Romsdal HF, Kristiansund Sykehus

location_facility: CENTRUM UROLOGIE Povazska Bystrica s.r.o

location_facility: Aghios Andreas General Hospital of Patras

location_facility: General Hospital of Athens "Ag. Olga" - Konstantopouleion

location_facility: Miskolci Semmelweis Ignác Egészségügyi Központ és Egyetemi Oktató Kórház Nonprofit Kft

location_facility: Vestre Viken HF, Sykehuset Asker og Baerum


title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction

acronym: PEGASUS

summary: This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.

ReferenceCitation: Bonaca MP, Im K, Magnani G, Bansilal S, Dellborg M, Storey RF, Bhatt DL, Steg PG, Cohen M, Johanson P, Braunwald E, Sabatine MS. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54. Eur Heart J. 2022 Nov 11. pii: ehac402. doi: 10.1093/eurheartj/ehac402. [Epub ahead of print]

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2:CD008834. doi: 10.1002/14651858.CD008834.pub4. Review.

ReferenceCitation: Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Špinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.

ReferenceCitation: Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, Lopez-Sendon J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.

ReferenceCitation: Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.

ReferenceCitation: Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.

ReferenceCitation: Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.

ReferenceCitation: Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.

ReferenceCitation: Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, López-Sendón J, Dellborg M, Diaz R, Van de Werf F, Corbalán R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.

ReferenceCitation: Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.

ReferenceCitation: Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.

ReferenceCitation: Bonaca MP, Storey RF, Theroux P, Steg PG, Bhatt DL, Cohen MC, Im K, Murphy SA, Magnani G, Ophuis TO, Rudah M, Parkhomenko A, Isaza D, Kamensky G, Goudev A, Montalescot G, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017 Sep 12;70(11):1368-1375. doi: 10.1016/j.jacc.2017.07.768.

ReferenceCitation: Magnuson EA, Li H, Wang K, Vilain K, Shafiq A, Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Braunwald E, Sabatine MS, Cohen DJ; PEGASUS-TIMI 54 Trial Investigators. Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction: Results From the PEGASUS-TIMI 54 Trial. J Am Coll Cardiol. 2017 Aug 1;70(5):527-538. doi: 10.1016/j.jacc.2017.05.063.

ReferenceCitation: Thomas MR, Angiolillo DJ, Bonaca MP, Ajjan RA, Judge HM, Rollini F, Franchi F, Ahsan AJ, Bhatt DL, Kuder JF, Steg PG, Cohen M, Muthusamy R, Sabatine MS, Storey RF. Consistent platelet inhibition with ticagrelor 60 mg twice-daily following myocardial infarction regardless of diabetes status. Thromb Haemost. 2017 May 3;117(5):940-947. doi: 10.1160/TH16-09-0703. Epub 2017 Mar 16.

ReferenceCitation: Bonaca MP, Goto S, Bhatt DL, Steg PG, Storey RF, Cohen M, Goodrich E, Mauri L, Ophuis TO, Ruda M, Špinar J, Seung KB, Hu D, Dalby AJ, Jensen E, Held P, Morrow DA, Braunwald E, Sabatine MS. Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). Circulation. 2016 Sep 20;134(12):861-71. doi: 10.1161/CIRCULATIONAHA.116.024637. Epub 2016 Aug 30.

ReferenceCitation: Bonaca MP, Bhatt DL, Oude Ophuis T, Steg PG, Storey R, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Theroux P, Hamm C, Špinar J, Kiss RG, Dalby AJ, Medina FA, Kontny F, Aylward PE, Jensen EC, Held P, Braunwald E, Sabatine MS. Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. JAMA Cardiol. 2016 Jul 1;1(4):425-32. doi: 10.1001/jamacardio.2016.1017.

ReferenceCitation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10. Review.

ReferenceCitation: Bonaca MP, Bhatt DL, Storey RF, Steg PG, Cohen M, Kuder J, Goodrich E, Nicolau JC, Parkhomenko A, López-Sendón J, Dellborg M, Dalby A, Špinar J, Aylward P, Corbalán R, Abola MTB, Jensen EC, Held P, Braunwald E, Sabatine MS. Ticagrelor for Prevention of Ischemic Events After Myocardial Infarction in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2016 Jun 14;67(23):2719-2728. doi: 10.1016/j.jacc.2016.03.524. Epub 2016 Apr 1.

ReferenceCitation: Bhatt DL, Bonaca MP, Bansilal S, Angiolillo DJ, Cohen M, Storey RF, Im K, Murphy SA, Held P, Braunwald E, Sabatine MS, Steg PG. Reduction in Ischemic Events With Ticagrelor in Diabetic Patients With Prior Myocardial Infarction in PEGASUS-TIMI 54. J Am Coll Cardiol. 2016 Jun 14;67(23):2732-2740. doi: 10.1016/j.jacc.2016.03.529. Epub 2016 Apr 1.

ReferenceCitation: Bonaca MP, Bhatt DL, Steg PG, Storey RF, Cohen M, Im K, Oude Ophuis T, Budaj A, Goto S, López-Sendón J, Diaz R, Dalby A, Van de Werf F, Ardissino D, Montalescot G, Aylward P, Magnani G, Jensen EC, Held P, Braunwald E, Sabatine MS. Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12 inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54. Eur Heart J. 2016 Apr 7;37(14):1133-42. doi: 10.1093/eurheartj/ehv531. Epub 2015 Oct 21.

ReferenceCitation: Bonaca MP, Bhatt DL, Braunwald E, Cohen M, Steg PG, Storey RF, Held P, Jensen EC, Sabatine MS. Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Am Heart J. 2014 Apr;167(4):437-444.e5. doi: 10.1016/j.ahj.2013.12.020. Epub 2014 Jan 6. Review.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Philippines
Japan
Romania
South Africa
Poland
Russian Federation
Australia
Argentina
Turkey
Norway
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands


acronym: CheckMate 915

title: A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma

ReferenceCitation: Weber JS, Schadendorf D, Del Vecchio M, Larkin J, Atkinson V, Schenker M, Pigozzo J, Gogas H, Dalle S, Meyer N, Ascierto PA, Sandhu S, Eigentler T, Gutzmer R, Hassel JC, Robert C, Carlino MS, Di Giacomo AM, Butler MO, Muñoz-Couselo E, Brown MP, Rutkowski P, Haydon A, Grob JJ, Schachter J, Queirolo P, de la Cruz-Merino L, van der Westhuizen A, Menzies AM, Re S, Bas T, de Pril V, Braverman J, Tenney DJ, Tang H, Long GV. Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915). J Clin Oncol. 2022 Sep 26:JCO2200533. doi: 10.1200/JCO.22.00533. [Epub ahead of print]

ReferenceCitation: Yoshino T, Oki E, Misumi T, Kotaka M, Manaka D, Eto T, Hasegawa J, Takagane A, Nakamura M, Kato T, Munemoto Y, Nakamura F, Bando H, Taniguchi H, Sakamoto Y, Shiozawa M, Nishi M, Horiuchi T, Yamagishi H, Sakamoto J, Mizushima T, Ohtsu A, Mori M. Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients With Stage III Colon Cancer: The Randomized Phase III ACHIEVE Trial. J Clin Oncol. 2022 Oct 10;40(29):3419-3429. doi: 10.1200/JCO.21.02628. Epub 2022 May 5.

location_country:
Poland
Brazil
Romania
Spain
Greece
Austria
Australia
Italy
Canada
New Zealand
Russian Federation
Switzerland
United Kingdom
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha

location_facility: Klinika Nowotworow Ukladowych i Uogolnionych

location_facility: Centre Hospitalier Universitaire Dijon Bocage

location_facility: Hospital Regional Universitario De Malaga

location_facility: Providence Cancer Center Oncology And Hematology Care

location_facility: Dermatovenerologicka klinika VFN a 1. LF UK

location_facility: Hospital Universitario Y Politecnico La Fe

location_facility: Washington University School Of Medicine

location_facility: The Beatson West Of Scotland Cancer Centre

location_facility: University Of Washington Cancer Care Alliance

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: UF Health Cancer Center at Orlando Health

summary: The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma


title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 in Patients With Advanced Solid Tumors

summary:
The primary goal of this Phase 1 study is to characterize the safety and tolerability of INCMGA00012 and establish the maximum tolerated dose (MTD) of INCMGA00012 administered on either every two week or every four week schedules of administration among patients with solid tumors. Pharmacokinetics, pharmacodynamics, and the anti-tumor activity of INCMGA00012 will also be assessed.

The purpose of Amendment 5 is to obtain additional safety experience at the newly defined recommended Phase 2 dose of 500 mg every 4 weeks in patients with endometrial cancer, specifically either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Additionally, every 3 week (Q3W) flat-dosing will be studied in an additional tumor agnostic cohort.

location_country:
Poland
Spain
Italy
Latvia
Australia
New Zealand
Finland
Lithuania
United Kingdom
Ukraine
United States
France
China
Belgium
Germany
Bulgaria

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Uzhgorod National University Clinical Base Uzhgorod Central City Clinical Hospital

location_facility: South Texas Accelerated Research Therapeutics

location_facility: The First Affiliated Hospital Sun Yat-Sen University

location_facility: SZPITALE WOJEWï¿½DZKIE W GDYNI SPï¿½LKA Z OGRANICZONA ODPOWIEDZIALNOSCIA

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Ko-Med Centra Kliniczne Osrodek Badan Klinicznych W Lublinie

location_facility: Szpital Kliniczny Przemienienia Panskiego

location_facility: Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Msw Z W-McO W Olsztynie

location_facility: Tongji Hospital Huazhong University of Science and Technology

location_facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

location_facility: Rmi Sumy Regional Clinical Oncology Dispensary

location_facility: University of Texas Md Anderson Cancer Center

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Katedra I Klinika Onkologii Um W Poznaniu Oddzial Ginekologii Onkologicznej

location_facility: Xiangya Hospital Central South University

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Medical University of Warsaw - 2Nd Department Obstetric and Gynecology

location_facility: Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

location_facility: Podillia Regional Center of Oncology - Chemotherapy Department

location_facility: STADTISCHE KLINIKUM MUNCHEN ï¿½ NEUPERLACH KLINIK FUR HAMATOLOGIE UND ONKOLOGIE

location_facility: Centro Integral Oncologico Clara Campal (Ciocc)

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Regional Clinical Oncology Center Facility of State Higher Educational Institution

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: The Second Hospital of Shanxi Medical University

location_facility: University Hospital Krakow, Department of Oncology

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: The First Affiliated Hospital of Xian Jiaotong University

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole


status: Terminated

acronym: SPIRIT

title: A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.

ReferenceCitation: Maspero J, Agache IO, Kamei T, Yoshida M, Boone B, Felser JM, Kawakami F, Knorr B, Lawrence D, Lehmann T, Wang W, Pedinoff AJ. Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial. Respir Res. 2021 Dec 11;22(1):311. doi: 10.1186/s12931-021-01904-8.

location_country:
Serbia
Saudi Arabia
Spain
United Kingdom
Lithuania
United States
Peru
Belgium
Japan
Philippines
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Malaysia
Singapore
Slovakia
Brazil
Lebanon
Canada
Switzerland
Guatemala
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Latvia
Estonia
Finland
France
Colombia
Netherlands

summary:
This study was a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study was to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.

The purpose of this study was to provide long-term safety data for QAW039 150 mg once daily and 450 mg once daily, compared with placebo, when added to GINA steps 3, 4, and 5 standard-of-care asthma therapy (GINA 2020) in adult and adolescent (≥12 years) patients with moderate-to-severe asthma. The study included 2 cohorts of patients:

Rollover patients who had completed any of the four Phase 3 pivotal efficacy studies with QAW039 (QAW039A2307, QAW039A2314, QAW039A2316, or QAW039A2317, hereafter referred to as Studies A2307, A2314, A2316, and A2317), thus providing data for a longer duration of exposure, and
New patients who had not previously participated in a study of QAW039, permitting an increase in the number of patients with long-term exposure to QAW039.

By including these 2 categories of patients, the total number of patients treated with QAW039 as well as the duration of exposure to QAW039 treatment was substantially increased, supporting evaluation of the safety profile of QAW039.

status_simplified: Unknown


title: Phase 2b, Multicenter, Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of Intravenous VIS410 in Addition to Oseltamivir (Tamiflu®) Compared With Oseltamivir Alone in Hospitalized Adults With Influenza A Infection Requiring Oxygen Support

summary: This study is to compare the efficacy and safety of VIS410 in combination with oseltamivir vs oseltamivir alone in severely ill subjects with influenza A infection requiring oxygen support.

lead_sponsor: Visterra, Inc.

location_country:
Belarus
Serbia
Latvia
Georgia
Australia
Estonia
Canada
New Zealand
Russian Federation
Spain
Thailand
Ukraine
United States
France
Singapore
South Africa
Belgium
Turkey
Malaysia
Bulgaria


title: A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

ReferenceCitation: Moore KN, Bookman M, Sehouli J, Miller A, Anderson C, Scambia G, Myers T, Taskiran C, Robison K, Mäenpää J, Willmott L, Colombo N, Thomes-Pepin J, Liontos M, Gold MA, Garcia Y, Sharma SK, Darus CJ, Aghajanian C, Okamoto A, Wu X, Safin R, Wu F, Molinero L, Maiya V, Khor VK, Lin YG, Pignata S. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol. 2021 Jun 10;39(17):1842-1855. doi: 10.1200/JCO.21.00306. Epub 2021 Apr 23. Erratum in: J Clin Oncol. 2021 Jul 20;39(21):2420.

ReferenceCitation: Moore KN, Pignata S. Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. A Phase III, multicenter, randomized study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer. Int J Gynecol Cancer. 2019 Jan 10. pii: ijgc-2018-000071. doi: 10.1136/ijgc-2018-000071. [Epub ahead of print]

location_country:
Spain
Italy
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Sweden
Brazil
China
Germany
Denmark
Greece
Finland
Korea, Republic of
France

location_facility: University of Colorado Hospital - Anschutz Cancer Pavilion

location_facility: The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

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

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins

location_facility: Monument Health Rapid City Hospital, Inc.

location_facility: Cooper Health System; MD Anderson Cancer Center

location_facility: Centro Integral Oncologico Clara Campal; Servicio de Oncología

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie

location_facility: Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes

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

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: University of Pennsylvania Health System; Cancer Center

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: The Royal North Shore Hospital; Northern Sydney Cancer Centre

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Onkologicka klinika UK 2.LF a FN v Motole

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: University of Kentucky; Gynecologic Oncology

location_facility: Fundacion Hospital de Alcorcon; Servicio de Oncologia

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: California Pacific Medical Center Research Institute

location_facility: Northeast Georgia Medical Center; Oncology Research Dept-5C

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej

location_facility: Koc University Medical Faculty; Department of Gynecology & Obstetrics

location_facility: Memorial Sloan Kettering Cancer Center; MSK Monmouth

location_facility: St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood

location_facility: Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH

location_facility: Chaim Sheba Medical Center; Obstetrics and Gynecology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Azienda Ospedaliera Universitaria Federico II

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

location_facility: St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Women's hospital school of medicine Zhejiang University

location_facility: Policlinico A. Gemelli e C.I.C.; Area Salute della Donna

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Arizona Oncology Associates, PC - HAL; Arizona Oncology Associates, PC - HAL

location_facility: Southwest Gynecologic Oncology Associates, Inc.

location_facility: St.Vincent Health System; Gynecologic Oncology

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: University of Wisconsin Hospital and Clinics

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

location_facility: Niigata University Medical & Dental Hospital

location_facility: Ospedale Degli Infermi - Faenza; Oncologia Medica

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

location_facility: Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie

location_facility: UT Southwestern Medical Center at Dallas; Department of Pathology

location_facility: Turku Uni Central Hospital; Gynaecology Dept

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

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: University Hospital of Patras Medical Oncology

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: DN Greenwald Center; DN Greenwald Center

location_facility: Sarasota Memorial Health Care System; Cancer Research Program

location_facility: Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology

location_facility: Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)

location_facility: University of Iowa Hospital & Clinic; Division of Hematology/Oncology

location_facility: Uni Hospital Linkoeping; Dept. of Oncology

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: University Hospital Ostrava; Fakultní nemocnice

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: IRCCS S. Raffaele; Ginecologia Oncologica

location_facility: Meir Medical Center; Obstetrics and Gynecology

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Tianjin Central Hospital of Gynecology Obstetrics.

location_facility: Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica

location_facility: Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie

location_facility: Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology

location_facility: Maine Medical Partners Women's Health; Gyn-Oncology

location_facility: Ospedale Silvestrini; Oncologia ed Ematologia

location_facility: A.O.Spedali Civili; Ostetricia e Ginecologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare

location_facility: A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica

location_facility: Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: University of California San Francisco Cancer Center

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Ohio State University, Arthur James Cancer Hospital

location_facility: Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Ginekologii Onkologicznej

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: University of Oklahoma; Stephenson Oklahoma Canc Ctr

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Dell Seton Medical Center at UT-Seton Infusion Center; Research Department

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

location_facility: New York Univ Medical Center; Obstetrics & Gynecolog

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

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Novant Health Presbyterain Medical Center

location_facility: Metro-Minnesota Community Oncology Research Consortium

location_facility: Texas Oncology San Antonio Medical Center

location_facility: Arcispedale Santa Maria Nuova; Oncologia

summary: This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.


intervention_type: Other

title: A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti-PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

ReferenceCitation: Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, Albiges L, Rini B, Tomita Y, Kann AG, Procopio G, Massari F, Zibelman M, Antonyan I, Huseni M, Basu D, Ci B, Leung W, Khan O, Dubey S, Bex A. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022 Oct 1;400(10358):1103-1116. doi: 10.1016/S0140-6736(22)01658-0. Epub 2022 Sep 10.

ReferenceCitation: Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Brazil
Canada
China
Germany
Denmark
Taiwan
Ireland
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit

location_facility: University of North Carolina at Chapel Hill

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie

location_facility: North York General Hospital; Inpatient Pharmacy

location_facility: University of California Irvine Medical Center

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: University of Rochester Medical Center; Urology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Altai Region Oncology Dispensory; Oncology

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec

location_facility: Ankara Uni School of Medicine; Medical Oncology

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: Sint Franciscus Gasthuis; Inwendige Geneeskunde

location_facility: Tokyo Women's Medical University Adachi Medical Center

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Narodowy Inst.Onkol.im.Skłodowskiej-Curie Państw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Clinic for Urology, Clinical Center of Serbia; Clinic for Urology

location_facility: Sourasky Medical Center; Oncology Department

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Cleveland Clinic Foundation; Hematology and Oncology

location_facility: The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology

location_facility: General University Hospital; CLINIC OF ONCOLOGY

location_facility: Medizinische Universität Wien; Universitätsklinik für Urologie, Arbeitsgruppe Nierenzellkarzinome

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

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

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: VU Medisch Centrum; VU University Medical Center

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Niigata University Medical & Dental Hospital

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

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: Lviv Com. City Clinical Hospital #8; Cardiol.Dept. for Pat. with Myocard.Infarction

location_facility: Chang Gung Medical Foundation-Linkou, Urinary Oncology

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: New York Oncology Hematology at Albany Medical Center

location_facility: P.A. Herzen Oncological Inst. ; Oncology

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Belinson Medical Center, Division of Oncology

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

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Emory Uni - Winship Cancer Center; Hematology/Oncology

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Division of Urological surgery; Department of surgery, Chulalongkorn University

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Clinic for Urology; Military Medical Academy

location_facility: Gazi University Medical Faculty; Department of İnternal Medicine

location_facility: Chaim Sheba medical center, Oncology division

location_facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Chemioterapii

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: China Medical University Hospital; Urology

location_facility: Vanderbilt University Medical Center; Vanderbilt University

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Loyola University Medical Center, Cardinal Bernardin Cancer Center

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

location_facility: National Taiwan University Hospital, Department of Urology

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: Fondazione IRCCS Policlinico San Matteo, Oncologia

location_facility: CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR

location_facility: Nouvel Hopital Civil - CHU Strasbourg; Urologie

location_facility: Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik

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

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

location_facility: Hillcrest Hospital; Hirsch Cancer Center

location_facility: McGill University Health Centre - Glen Site

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

location_facility: University of Texas Southwestern Medical Center

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

location_facility: Royal Brisbane & Women's Hosp; Cancer Care Serv

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU

summary: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.


title: AssEssment of CoMorbidities & Atrial ArRhythmiA Burden in DuaL-Chamber PaceD Patients

acronym: EMERALD

summary: The purpose of this study is to evaluate the incidence and evolution over-time of co-morbidities in a general dual-chamber pacemaker population (n=2188 patients) through a 2 years follow-up.

lead_sponsor: MicroPort CRM

location_country:
Denmark
Spain
Italy
Australia
Netherlands
Canada
Switzerland
United States
France
Belgium
Japan
Germany

location_facility: Gemeinschaftspraxis Dr. Loebe - Dr. Weissbrodt

location_facility: Med. Martina Trummel Praxis Innere Medizin / Kardiologie

location_facility: Sohien und Hufeland Klinikum Weimar Gmbh

location_facility: Clinique & Maternité Sainte-Elisabeth Namur

location_facility: Kardiocentrum Frankfurt and der Klinik Rotes Kreuz

location_facility: Kardiologische - angiologische Praxis Dr. med. Jörg Walter

location_facility: Complete Cardiology Care Live Oak Street

location_facility: National Hospital Organization Oita Medical Center

location_facility: Gemeinschaftspraxis Dr. Bemmann, Dr. Sadowski, Dr. Boehme

location_facility: Staedt. Linikum Medizinische Klinik Lueneburg

location_facility: Hospital General Universitario de Alicante

location_facility: Ospedale OO.OO.San Giovanni e Ruggi d'Aragona

location_facility: Baerenfaenger Dr. Petra Private Practice

location_facility: Gemeinschaftspraxis Dres.Med.U. Heinrich Und Dr Predel

location_facility: Centre hospitalier de la Région d'Annecy

location_facility: FOWIS e. V., Förderverein für die medizinische Wissenschaft und Schulung


title: Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

acronym: CheckMate 816

summary:
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.

This study has multiple primary endpoints.

ReferenceCitation: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.

location_country:
Taiwan
Brazil
Spain
Greece
Italy
Argentina
Canada
Hungary
Korea, Republic of
United States
France
China
Turkey
Romania
Japan

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du-Quebec


title: Prevention of Atrial Arrhythmia in Patients Without AV Conduction Disease

summary: This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.

lead_sponsor: LivaNova

location_country:
Spain
Italy
United Kingdom
Monaco
United States
France
Belgium
Germany

location_facility: CHRU du Morvan Hôpital la Cavale Blanche

location_facility: Passaic Beth Israel Regional Medical Center

location_facility: Johannes Gutenberg-Universität - Mainz Klinikum

location_facility: University of Mississippi Medical Center

location_facility: Complejo Hospitalario Universitario de Vigo (CHUVI)

intervention_type: Device