summary: A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

ReferenceCitation: Galsky MD, Hoimes CJ, Necchi A, Shore N, Witjes JA, Steinberg G, Bedke J, Nishiyama H, Fang X, Kataria R, Sbar E, Jia X, Siefker-Radtke A. Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303. Future Oncol. 2021 Aug;17(24):3137-3150. doi: 10.2217/fon-2021-0273. Epub 2021 May 19.

repository_institution: Radboud University - Radboud Repository

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 0004)

location_facility: Korea University Anam Hospital ( Site 1351)

location_facility: Southside Cancer Care Centre ( Site 1252)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0105)

location_facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 0033)

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

location_facility: Tallaght University Hospital ( Site 0710)

location_facility: A.O.U. Policlinico Vittorio Emanuele - Presidio Gaspare Rodolico ( Site 0559)

location_facility: Yitzhak Shamir Medical Center ( Site 0805)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0254)

location_facility: Instituto Nacional de Cancerologia ( Site 0256)

location_facility: Sunnybrook Research Institute ( Site 0110)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0456)

location_facility: Tokushima University Hospital ( Site 1514)

location_facility: UMass Memorial Medical Center ( Site 0051)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 0951)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0910)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0557)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0519)

location_facility: Odense Universitetshospital ( Site 0403)

location_facility: Kursk Regional Clinical Oncology Dispensary ( Site 0854)

location_facility: Policlinico Gemelli di Roma ( Site 0558)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 0856)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 1010)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0962)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0662)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0021)

location_facility: FSBI ""United Hospital with Polyclinic"" of the Administrative Department of the President of the Ru

location_facility: CHU de Montpellier - Hopital Saint-Eloi ( Site 0469)

location_facility: Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0901)

location_facility: New England Cancer Specialists ( Site 0070)

location_facility: Sapporo Medical University Hospital ( Site 1501)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0512)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1002)

location_facility: National Cancer Center Hospital East ( Site 1504)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1062)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 1051)

location_facility: Imperial College Healthcare NHS Trust ( Site 0721)

location_facility: Seoul National University Hospital ( Site 1352)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0810)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0516)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0453)

location_facility: Saratov State Medical University n.a. V.I.Razumovskiy ( Site 0866)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 1057)

location_facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0005)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0959)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0904)

location_facility: Herlev og Gentofte Hospital. ( Site 0402)

location_facility: Saitama Medical University International Medical Center ( Site 1505)

location_facility: Mid North Coast Cancer Institute ( Site 1256)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 1007)

location_facility: Hospital Nuestra Sra. de Valme ( Site 0658)

location_facility: The Royal Marsden Foundation Trust ( Site 0702)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0253)

location_facility: Clinic of Bashkortostan State Medical University ( Site 0869)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

location_facility: Georgetown University Medical Center ( Site 0022)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0865)

location_facility: CNPE "Regional Center of Oncology" ( Site 0958)

location_facility: Seoul National University Bundang Hospital ( Site 1356)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0963)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1060)

location_facility: Rigshospitalet University Hospital ( Site 0401)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0560)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Kyiv City Clinical Oncology Center ( Site 0960)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 0913)

location_facility: Norfolk & Norwich University Hospital NHS Foundation Trust ( Site 0725)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

location_facility: Nara Medical University Hospital ( Site 1510)

location_facility: Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 1068)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1452)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0906)

location_facility: University Hospitals Cleveland Medical Center ( Site 0038)

location_facility: Lviv Regional Clinical Hospital ( Site 0955)

location_facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie ( Site 0457)

location_facility: Regional Oncological Hospital ( Site 0956)

location_facility: Clinical Hospital Saint Luka ( Site 0867)

location_facility: Fondazione Salvatore Maugeri IRCCS. ( Site 0554)

location_facility: Shaare Zedek Medical Center ( Site 0809)

location_facility: University Hospital Waterford ( Site 0723)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0660)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0502)

location_facility: Kingston Health Sciences Centre ( Site 0103)

location_facility: H. de Gerona Dr. Josep Trueta ( Site 0651)

location_facility: Charleston Area Medical Center ( Site 0023)

location_facility: Istituto Nazionale Studio e Cura dei Tumori ( Site 0551)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0911)

location_facility: Nova Scotia Health Authority ( Site 0109)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Hospital Universitario San Carlos ( Site 0663)

location_facility: Inova Schar Cancer Institute ( Site 0007)

location_facility: New York University Perlmutter Cancer Center ( Site 0008)

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0967)

location_facility: Reg. Clinical Center of Urology and Nephrology n.a. V. I. Shapoval ( Site 0969)

location_facility: Hirosaki University Hospital ( Site 1502)

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. ( Site 0300)

location_facility: Hospital Universitario Quiron Madrid ( Site 0657)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0909)

location_facility: Tokyo Medical and Dental University Hospital ( Site 1517)

location_facility: Hospital San Pedro de Alcantara ( Site 0654)

location_facility: Leningrad Regional Oncology Center ( Site 0868)

location_facility: UNM Comprehensive Cancer Center-Clinical Research Office ( Site 0045)

location_facility: Providence Saint John's Health Center ( Site 0075)

location_facility: Northwest Medical Specialties, PLLC ( Site 0061)

location_facility: Kent and Canterbury Hospital ( Site 0709)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)

location_facility: Osaka Metropolitan University Hospital ( Site 1512)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 1513)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori ( Site 0552)

location_facility: Universitaetsklinikum Erlangen ( Site 0505)

location_facility: Central Texas Veterans Healthcare System ( Site 0057)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0802)

location_facility: Hospital Universitario La Paz ( Site 0661)

location_facility: CHU UCL Namur Site de Godinne ( Site 0354)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0515)

location_facility: Peninsula Health Frankston Hospital ( Site 1258)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 0852)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0857)

location_facility: University of Tsukuba Hospital ( Site 1503)

title: A Phase 3, Randomized, Double-blind Study to Evaluate Perioperative Pembrolizumab (MK-3475) + Neoadjuvant Chemotherapy Versus Perioperative Placebo + Neoadjuvant Chemotherapy in Cisplatin-eligible Participants With Muscle-invasive Bladder Cancer (KEYNOTE-866)

location_country:
Germany
Ireland
Poland
Australia
Japan
Thailand
Turkey
Canada
France
Hungary
Denmark
United States
Ukraine
Belgium
Italy
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Russian Federation
Israel


type: EudraCT Number

title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

summary: The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Japan
Belgium
United States
China
Korea, Republic of
Spain
Chile
Canada
Russian Federation
France

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Moscow 1st State Med.Univ.n.a.I.M.Sechenov

location_facility: NewYork-Presbyterian/Weill Cornell Medical Center

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

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

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: University of Utah Health Sciences Center

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

location_facility: Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA

location_facility: Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.

location_facility: The First Hospital of China Medical University

location_facility: University of Texas Southwestern Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: Penn State Milton S. Hershey Medical Center

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

location_facility: Instituto Médico de la Fundación Estudios Clínicos

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: University of Florida College of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Azienda Ospedaliera Policlinico di Modena

location_facility: Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: Registry Identifier

title: Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease

acronym: FLOW

summary: The researchers are doing this study to see if semaglutide can slow down the growth and worsening of chronic kidney disease in people with type 2 diabetes. Participants will get semaglutide (active medicine) or placebo ('dummy medicine'). This is known as participants' study medicine - which treatment participants get is decided by chance. Semaglutide is a medicine, doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine in a skin fold once a week. The study will close when there is enough information collected to show clear result of the study. The total time participants will be in this study is about 3 to 5 years, but it could be longer.

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Rossing P, Baeres FMM, Bakris G, Bosch-Traberg H, Gislum M, Gough SCL, Idorn T, Lawson J, Mahaffey KW, Mann JFE, Mersebach H, Perkovic V, Tuttle K, Pratley R. The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease. Nephrol Dial Transplant. 2023 Aug 31;38(9):2041-2051. doi: 10.1093/ndt/gfad009. Erratum In: Nephrol Dial Transplant. 2023 Nov 30;:

ReferenceType: derived

ReferenceCitation: Cohen S, Sternlicht H, Bakris GL. Mineralocorticoid Receptor Antagonists in the Treatment of Diabetic Kidney Disease: Their Application in the Era of SGLT2 Inhibitors and GLP-1 Receptor Agonists. Curr Diab Rep. 2022 May;22(5):213-218. doi: 10.1007/s11892-022-01461-4. Epub 2022 Apr 20.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Springer-Nature

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Slovakia
Hungary
United States
Ukraine
India
Belgium
China
Malaysia
Italy
United Kingdom
Netherlands
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel

status_simplified: Ongoing


acronym: POLAR-M

lead_sponsor: Egetis Therapeutics

summary: This study evaluates the investigational drug PledOx in the prevention of chronic chemotherapy induced peripheral neuropathy (CIPN) induced by the drug oxaliplatin.

ReferenceCitation: Pfeiffer P, Lustberg M, Nasstrom J, Carlsson S, Persson A, Nagahama F, Cavaletti G, Glimelius B, Muro K. Calmangafodipir for Prevention of Oxaliplatin-Induced Peripheral Neuropathy: Two Placebo-Controlled, Randomized Phase 3 Studies (POLAR-A/POLAR-M). JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac075. doi: 10.1093/jncics/pkac075.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;boa.unimib.it;sdu.dk

unpaywall_oa_status: gold

publisher_dissemination: Oxford University Press

sponsor_collaborators:
Egetis Therapeutics
Solasia Pharma K.K.

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Centre Hospitalier Départemental de Vendée - Unité de recherche clinique

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

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

location_facility: KMUH: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Hôpital Nord Franche-Comté Site du Mittan

location_facility: Chonnam National University Hwasun Hospital

location_facility: NCKUH: National Cheng Kung University Hospital

location_facility: St. Marianna University School of Medicine Hospital

status: Terminated

title: A Phase 3, Double-blind, Multicenter, Placebo-controlled Study of PledOx Used on Top of Modified FOLFOX6 (5-FU/FA and Oxaliplatin) to Prevent Chemotherapy Induced Peripheral Neuropathy (CIPN) in Patients With First-line mCRC

primary_purpose: Prevention

source: euctr

location_country:
Germany
Italy
Hungary
Hong Kong
United Kingdom
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
France

ipd_sharing: No

status_simplified: Unknown


lead_sponsor: Eisai Inc.

summary: This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080) versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of advanced endometrial cancer. Participants will be randomly assigned to receive either pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS) and overall survival (OS) when compared to treatment of physician's choice.

ReferenceCitation: Makker V, Colombo N, Casado Herraez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D; Study 309-KEYNOTE-775 Investigators. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. N Engl J Med. 2022 Feb 3;386(5):437-448. doi: 10.1056/NEJMoa2108330. Epub 2022 Jan 19.

oa_host_type: publisher

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Eisai Inc.
Merck Sharp & Dohme LLC

location_facility: FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Florence Nightingale Gayrettepe Hastanesi

location_facility: Faculdade de Medicina da Universidade Federal de Minas Gerais

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II

location_facility: Investigacion Onco Farmaceutica S de RL de CV

location_facility: Instituto do Cancer de Sao Paulo - ICESP

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Pomorski Uniwersytet Medyczny w Szczecinie

location_facility: Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale

location_facility: Tomsk National Research Medical Center of Russian Academy of Sciences

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

location_facility: Azienda Ospedaliera per l Emergenza Cannizzaro

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals

location_facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F.

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec

location_facility: Hospital Universitario y Politecnico La Fe de Valencia

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o.

location_facility: Hospital General Universitari Vall d Hebron

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan

location_facility: Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie

location_facility: Alivia Clinica de Alta Especialidad S.A. de C.V.

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Texas Oncology-San Antonio Medical Center

location_facility: Instituto de Investigaciones Metabolicas

location_facility: Georgia Cancer Center at Augusta University

location_facility: Mordovia Republican Oncological Dispensary

location_facility: SPb SBHI City Clinical Oncological Dispensary

location_facility: Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia

location_facility: John Theurer Cancer Center at Hackensack University Med Ctr

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

location_facility: Institut Regional du Cancer de Montpellier - ICM

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM

location_facility: Szpital Kliniczny im Ks Anny Mazowieckiej

location_facility: Chang Gung Medical Foundation. Linkou Branch

location_facility: Groupe Hospitalier Broca Cochin Hotel Dieu

title: A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Colombia
United States
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS

acronym: DUPLEX

summary: To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).

ReferenceCitation: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.

oa_host_type: repository

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: Travere Therapeutics, Inc.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Croatia
Czechia
Canada
France
Portugal
Hong Kong
Denmark
United States
Belgium
Estonia
Italy
United Kingdom
Korea, Republic of
Spain
Taiwan
Sweden


title: A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema

acronym: KITE

summary: The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

ipd_sharing: Undecided

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 ww.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Turkey
Czechia
France
Lithuania
Slovakia
Hungary
Denmark
Switzerland
Latvia
India
Lebanon
Belgium
Malaysia
Estonia
Norway
Singapore
Korea, Republic of
Taiwan
Bulgaria
Russian Federation
Sweden


title: A Randomized Phase 3 Comparison of IMO-2125 With Ipilimumab Versus Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma (ILLUMINATE-301)

summary: A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

lead_sponsor: Idera Pharmaceuticals, Inc.

sponsor_collaborators:
Idera Pharmaceuticals, Inc.
Bristol-Myers Squibb

location_country:
Germany
Italy
United Kingdom
Australia
Sweden
Netherlands
United States
Spain
Czechia
Canada
France

location_facility: The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg

location_facility: Mount Sinai Medical Center of Florida, Inc.

location_facility: Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: University of Florida Health Cancer Center - Orlando Health

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Alberta Health Services Cross Cancer Institute

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center

location_facility: Fakultni nemocnice Olomouc - Oncology clinic

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

location_facility: Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie

location_facility: Azienda Ospedaliero-Universitaria di Modena

location_facility: University of California, Los Angeles (UCLA)

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino IST

location_facility: Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale"

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Azienda Ospedaliero Universitaria Senese

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: University of Alabama at Birmingham (UAB)

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study to Evaluate the Efficacy and Safety of BIIB074 (Vixotrigine) in Treating Pain Experienced by Subjects With Confirmed Small Fiber Neuropathy That is Idiopathic or Associated With Diabetes Mellitus

summary:
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or associated with diabetes mellitus. A secondary endpoint that relates to the primary objective is the change from Randomization to Week 12 of the double-blind period in mean average daily pain score.

The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic pain quality, sleep interference due to pain, patient global impression, use of rescue medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety and tolerability of BIIB074 in participants with SFN; and to characterize the pharmacokinetics (PK) of BIIB074 in participants with SFN.

lead_sponsor: Biogen

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Netherlands
Switzerland
Spain
Greece
Czechia
Bulgaria
Canada
France

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois

location_facility: Hospital General Universitario de Alicante

location_facility: Hausarzt- und Diabetologische Schwerpunktpraxis

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Gemeinschaftspraxis Diabeteszentrum Dortmund Dr.med. Klaus Busch

location_facility: Azienda Ospedaliero Univeraitaria Pisana

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: CHU Clermond Ferrand - Hopital Gabriel Montpied

location_facility: Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice

location_facility: Regionalna Poradnia Diabetologiczna Zytkiewicz-Jaruga,Stasinska


title: A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

acronym: IMROZ

summary:
Primary Objective:

-To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in patients with newly diagnosed multiple myeloma (NDMM) not eligible for transplant.

Secondary Objectives:

To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms:
Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria.
Minimal residual disease (MRD) negativity rate in patients with CR.
Very good partial response or better rate, as defined by the IMWG criteria.
Overall survival (OS).
To evaluate the overall response rate (ORR) as per IMWG criteria.
To evaluate the time to progression (TTP) overall and by MRD status.
To evaluate PFS by MRD status.
To evaluate the duration of response (DOR) overall and by MRD status.
To evaluate time to first response (TT1R).
To evaluate time to best response (TTBR).
To evaluate progression-free survival on next line of therapy (PFS2).
To evaluate the sustained MRD negativity >12 months rate.
To evaluate safety.
To determine the pharmacokinetic (PK) profile of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (IVRd arm only).
To evaluate the immunogenicity of isatuximab in patients receiving isatuximab (IVRd and crossover arms).
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.

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

lead_sponsor: Sanofi

location_country:
Germany
Poland
New Zealand
Australia
Japan
Turkey
Czechia
France
Lithuania
Portugal
Denmark
United States
Belgium
China
Italy
Mexico
Spain
Greece
Taiwan
Russian Federation
Sweden

location_facility:
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Investigational Site Number :6160003
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Investigational Site Number :1580002
Investigational Site Number :2030001
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acronym: SENSCIS (TM)-ON

summary: The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Vanderbilt University Medical Center - Vanderbilt Lung Institute at 100 Oaks

location_facility: University of Utah Health Sciences Center

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: University of Texas Southwestern Medical Center

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: CEMER-Centro Medico De Enfermedades Respiratorias

location_facility: National Hospital Organization Himeji Medical Center

location_facility: B.J. Medical College and Sasoon General Hospital

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Specialist Allergy-Internist Center ALL-MED

location_facility: Leids Universitair Medisch Centrum (LUMC)

location_facility: University of Florida College of Medicine

location_facility: The University of Texas Health Science Center at Houston

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: Washington University School of Medicine

location_facility: Azienda Universitaria-Universita' La Sapienza

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Clinical Rheumatology Research Center Sahlgrenska

location_facility: EMED, Center of Medical Services,Private Prac,Rzeszow

location_facility: A.O Universitaria - Università degli Studi della Campania Luigi Vanvitelli

location_facility: Columbia University Medical Center-New York Presbyterian Hospital

location_facility: Institute of Rheumatology Tokyo Women's Medical University

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Hospital Clínico Reg. de Concepción "Dr. G. Grant Benavente"

location_facility: The First Hospital of Chinese Medical University

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

title: An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Portugal
Denmark
Switzerland
United States
India
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Israel


lead_sponsor: Genentech, Inc.

summary: This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.

ReferenceCitation: Teng E, Manser PT, Pickthorn K, Brunstein F, Blendstrup M, Sanabria Bohorquez S, Wildsmith KR, Toth B, Dolton M, Ramakrishnan V, Bobbala A, Sikkes SAM, Ward M, Fuji RN, Kerchner GA; Tauriel Investigators. Safety and Efficacy of Semorinemab in Individuals With Prodromal to Mild Alzheimer Disease: A Randomized Clinical Trial. JAMA Neurol. 2022 Aug 1;79(8):758-767. doi: 10.1001/jamaneurol.2022.1375.

oa_colors: green hybrid

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

publisher_dissemination: American Medical Association

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: Klinikum Bayreuth; Krankenhaus Hohe Warte

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hospital Universitario Reina Sofia; Servicio de Neurologia

location_facility: Stanford Neuroscience Health Center (SNHC)

location_facility: Azienda Ospedaliero Universitaria San Martino; Dip. di Neuroscienze Oftalmologia e Genetica

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Eastern Clinical Research Unit; Pharmacy

location_facility: IRCCS Neuromed; Neurologia I-Centro studio e cura delle demenze e UVA

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Center For Clinical and Basic Research (Ccbr); Site Management Organisation

location_facility: Alzheimer's Research and Treatment Center

location_facility: Health Partners Institute for Education and Research

location_facility: Hospital Universitario Dr. Peset; Servicio de Neurologia

location_facility: Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Neurologisch-psychiatrische Praxis am Brosepark

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Empire Neurology PC; MS Center of Northeastern NY

location_facility: Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Neurologie

location_facility: Hospital Perpetuo Socorro, Servicio de Geriatria

location_facility: PALLMED Sp. z o.o. prowadząca NZOZ DOM SUE RYDER

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Southern Illinois University, School of Medicine

location_facility: The Alfred Hospital, Melbourne; Thrombosis and Haemostasis Unit

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Studienambulanz emovis GmbH; St. Joseph Krankenhaus

location_facility: Skane University Hospital Malmo/Lund, Dept.of Hematology and Coagulation Disorders

location_facility: New Orleans Center For Clinical Research

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Az. Osp. C. Panico; Rep. Ematologia E Trapianto

location_facility: Senior Sp. Z O.O. Poradnia Psychogeriatryczna

location_facility: Sahlgrenska Univ Hospital Mölndal; Department of Nephrology

location_facility: Parkwood Institute, Mental Health Care Building

location_facility: CHU Hautepierre; ACTR Association Recherche Clinique Rhumatologie

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Advanced Memory Research Institute of NJ

location_facility: HammondCare Aged Psychiatry Clinical Trials

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

location_facility: Hospital de Cantoblanco; Servicio de Geriatria

location_facility: JBN Medical Diagnostic Services; Clinical Trials Division

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Prodromal to Mild Alzheimer's Disease

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Australia
Sweden
Netherlands
Belgium
United States
Spain
Canada
France


title: A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

acronym: TULIP

summary: The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

lead_sponsor: Byondis B.V.

location_country:
Italy
United Kingdom
Singapore
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Texas Oncology PA (Texas Oncology-Dallas Presbyterian Hospital)

location_facility: Texas Oncology- Baylor Charles A. Sammor

location_facility: BC Cancer Agency Centre for the Southern Interior

location_facility: Istituto Nazionale dei Tumori Regina Elena

location_facility: Hospital General Universitario de Alicante

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitari Vall d'Hebron Vall d' Hebron Institute of Oncology (VHIO)


title: Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia

summary: This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

status: Recruiting

lead_sponsor: Arog Pharmaceuticals, Inc.

location_country:
Germany
Italy
United States
Spain
Canada
France

location_facility: Hospital Universitario Central de Asturias (HUCA)

location_facility: Institut Universitaire du Cancer Toulouse

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

location_facility: Hospital Clinico Universitario de Santiago

location_facility: IRCCS Foundation Ca 'Granda Ospedale Maggiore Policlinico

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

location_facility: Policlinico GB Rossi, University Hospital Verona

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Hospital Gregorio Maranon Servicio de Hematologia y Hemoterapia

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Hospital Center of Versailles (Le Chesnay)

location_facility: Ospedale Santa Maria delle Croci di Ravenna


acronym: NAC/Adj GEJ Adenocarcinoma with Chemo (XP/FP) vs Chemo + Pembro Study

lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to evaluate the efficacy of pembrolizumab (MK-3745) in the neoadjuvant (prior to surgery) or adjuvant (after surgery) treatment of previously untreated adults with gastric and gastroesophageal junction (GEJ) adenocarcinoma.

The primary study hypotheses are that:

Neoadjuvant and adjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab is superior to neoadjuvant and adjuvant placebo plus chemotherapy, followed by adjuvant placebo in terms of Event-free Survival (EFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), and
Neoadjuvant pembrolizumab plus chemotherapy is superior to neoadjuvant placebo plus chemotherapy in terms of rate of Pathological Complete Response (pathCR) at the time of surgery.

With Amendment 10, upon study completion, participants will be discontinued and may be enrolled in an extension study.

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.

license: cc-by-nc

license_normalized: cc-by-nc

evidence: open (via page says license)

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Bang YJ, Van Cutsem E, Fuchs CS, Ohtsu A, Tabernero J, Ilson DH, Hyung WJ, Strong VE, Goetze TO, Yoshikawa T, Tang LH, Hwang PMT, Webb N, Adelberg D, Shitara K. KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer. Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.

publisher_dissemination: Future Science Ltd

location_facility: Sunnybrook Research Institute ( Site 0032)

location_facility: Klinikum der Universitaet in Muenchen ( Site 0446)

location_facility: Vilniaus Universiteto Ligonine Santaros Klinikos ( Site 0568)

location_facility: Kaluga Regional Clinical Oncology Center ( Site 0345)

location_facility: Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 0448)

location_facility: City Clinical Hosp.4 of DCC ( Site 0325)

location_facility: Szpital Uniwersytecki w Krakowie ( Site 0352)

location_facility: Hospital Israelita Albert Einstein ( Site 0309)

location_facility: City clinical oncological dispensary ( Site 0336)

location_facility: Seoul National University Hospital -SNUH- ( Site 0080)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0432)

location_facility: Korea University Anam Hospital ( Site 0084)

location_facility: Instituto Nacional Do Cancer Jose Alencar Gomes Da Silva ( Site 0307)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0349)

location_facility: Kobe City Medical Center General Hospital ( Site 0181)

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 0589)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 0068)

location_facility: Toyama Prefectural Central Hospital ( Site 0163)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0461)

location_facility: Nacionalinis Vezio Institutas ( Site 0569)

location_facility: Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 0445)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0302)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0353)

location_facility: Kansai Medical University Hospital ( Site 0190)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 0383)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0429)

location_facility: National Cancer Center Hospital East ( Site 0178)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 0591)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0187)

location_facility: Aichi Cancer Center Hospital ( Site 0165)

location_facility: Blokhin National Medical Oncology ( Site 0494)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 0351)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0286)

location_facility: Seoul National University Bundang Hospital ( Site 0085)

location_facility: National Cancer Centre Singapore ( Site 0097)

location_facility: National Cancer Center Hospital ( Site 0179)

location_facility: National Cheng Kung University Hospital ( Site 0067)

location_facility: Osaka International Cancer Institute ( Site 0161)

location_facility: Medizinische Hochschule Hannover ( Site 0449)

location_facility: Kyungpook National University Chilgok Hospital ( Site 0089)

location_facility: Ninewells Hospital and Medical School ( Site 0406)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0285)

location_facility: Instituto Clinico del Sur. ICOS ( Site 0290)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0337)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0305)

location_facility: Leningrad Regional Oncology Center ( Site 0335)

location_facility: Niigata Cancer Center Hospital ( Site 0169)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0319)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0038)

location_facility: Kyiv City Clinical Oncology Center ( Site 0590)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 0434)

location_facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0042)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0176)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0172)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0185)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0361)

location_facility: National Taiwan University Hospital ( Site 0063)

location_facility: Universitaetsklinikum Freiburg ( Site 0450)

location_facility: CHU Reims - Hopital Robert Debre ( Site 0465)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0186)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0496)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 0526)

location_facility: Virginia Cancer Specialists, PC ( Site 0010)

location_facility: CISSS de la Monteregie-Centre ( Site 0039)

location_facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu ( Site 0358)

location_facility: Ivano-Frankivsk Regional Oncology Clinical Dispensary ( Site 0321)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0400)

location_facility: Severance Hospital Yonsei University Health System ( Site 0081)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0344)

location_facility: University Malaya Medical Centre ( Site 0143)

location_facility: CHU Toulouse - Hopital Rangueil ( Site 0470)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0430)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0308)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0304)

location_facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0474)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0407)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0301)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0019)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 0183)

location_facility: Hokkaido University Hospital ( Site 0160)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0431)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 0171)

location_facility: Medizinische klinilk und Poliklinik Johannes Gutenberg Univ ( Site 0455)

location_facility: Osaka General Medical Center ( Site 0159)

location_facility: CHU Poitiers - Pole Regional de Cancerologie ( Site 0467)

location_facility: The University of Chicago Medical Center ( Site 0004)

location_facility: University of Utah, Huntsman Cancer Institute ( Site 0012)

location_facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 0454)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 0066)

location_facility: Roswell Park Cancer Institute ( Site 0001)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0064)

location_facility: Instituto do Cancer do Ceara ( Site 0311)

location_facility: Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0018)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0040)

location_facility: Institut Mutualiste Montsouris ( Site 0463)

location_facility: Ibaraki Prefectural Central Hospital ( Site 0177)

location_facility: National University Hospital ( Site 0095)

location_facility: The Royal Marsden Foundation Trust ( Site 0405)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0035)

location_facility: Osaka Medical College Hospital ( Site 0168)

location_facility: Hospital Clinico Universidad de Chile ( Site 0287)

location_facility: Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0299)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0354)

location_facility: Kumamoto University Hospital ( Site 0164)

location_facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0260)

location_facility: Kochi Health Sciences Center ( Site 0189)

location_facility: Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0469)

location_facility: Royal Free London NHS Foundation Trust ( Site 0403)

location_facility: IRCCS Policlinico San Donato ( Site 0433)

location_facility: Chonnam National University Hwasun Hospital ( Site 0083)

location_facility: Iwate Medical University Hospital ( Site 0184)

location_facility: Gachon University Gil Medical Center ( Site 0087)

location_facility: Weill Cornell Medical Center ( Site 0023)

location_facility: Institut du Cancer de Montpellier ( Site 0473)

location_facility: Imperial College Healthcare NHS Trust ( Site 0402)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 0363)

location_facility: Riga East Clinical University Hospital ( Site 0550)

location_facility: SMG-SNU BORAMAE Medical Center ( Site 0086)

location_facility: The Christie NHS Foundation Trust ( Site 0397)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0338)

location_facility: CHU UCL Namur Site de Godinne ( Site 0485)

title: A Phase III, Randomized, Double-Blind, Clinical Trial of Pembrolizumab (MK-3475) Plus Chemotherapy (XP or FP) Versus Placebo Plus Chemotherapy (XP or FP) as Neoadjuvant/Adjuvant Treatment for Subjects With Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma (KEYNOTE-585)

location_country:
Germany
Poland
Japan
Brazil
Chile
Canada
France
Lithuania
United States
Latvia
Ukraine
Belgium
China
Malaysia
Estonia
Philippines
Italy
Guatemala
United Kingdom
Singapore
Korea, Republic of
Taiwan
Russian Federation
Israel


acronym: CheckMate 914

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to determine whether nivolmab alone or the combination of nivolumab and ipilimumab versus placebo, is safe and effective for delaying or preventing recurrence of cancer in participants who have experienced partial or entire removal of a kidney.

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.

publisher_dissemination: Elsevier

location_facility:
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title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab vs Placebo in Participants With Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Switzerland
United States
Romania
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Spain
Russian Federation


lead_sponsor: Regeneron Pharmaceuticals

summary: The primary objective is to estimate the objective response rate (ORR) for metastatic Basal Cell Carcinoma (BCC) (group 1) and for unresectable locally advanced BCC (group 2) when treated with cemiplimab as a monotherapy

ReferenceCitation: Stratigos AJ, Sekulic A, Peris K, Bechter O, Prey S, Kaatz M, Lewis KD, Basset-Seguin N, Chang ALS, Dalle S, Orland AF, Licitra L, Robert C, Ulrich C, Hauschild A, Migden MR, Dummer R, Li S, Yoo SY, Mohan K, Coates E, Jankovic V, Fiaschi N, Okoye E, Bassukas ID, Loquai C, De Giorgi V, Eroglu Z, Gutzmer R, Ulrich J, Puig S, Seebach F, Thurston G, Weinreich DM, Yancopoulos GD, Lowy I, Bowler T, Fury MG. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. Lancet Oncol. 2021 Jun;22(6):848-857. doi: 10.1016/S1470-2045(21)00126-1. Epub 2021 May 14.

ReferenceCitation: Li R, Lee G, Huang M, El-Sherief A. Rare basal cell metastasis of a basal-squamous skin collision tumour to the lung and axillary lymph node. BMJ Case Rep. 2019 Oct 3;12(10):e231487. doi: 10.1136/bcr-2019-231487.

repository_institution: PubMed Central - Europe PMC

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

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: British Medical Journal

sponsor_collaborators:
Regeneron Pharmaceuticals
Sanofi

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Stanford Medicine Outpatient Center - Stanford Dermatology Clinic-Stanford University School of Medicine

location_facility: Centre Hospitalier Lyon-Sud -Hospices Civils de Lyon Groupement Hospitalier Sud

location_facility: Klinik Fur Dermatologie Und Allergollogie

location_facility: London Regional Cancer Program, London Hsc

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Clinical Research Center of the Carolinas

location_facility: University of Colorado Hospital, Anschutz Outpatient Pavilion

location_facility: Medizinische Universitaet Innsbruck, Universitaetsklinik fuer Dermatologie, Venerologie und Allergologie

location_facility: UCSF Helen Dillion Family Cancer Care Center

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Saint-André - Hôpital Saint-André

location_facility: U.O.Dermatologia Azienda Sanitaria Firenze Universita' Firenze

location_facility: James Cancer Hospital and Solove Research Institute

location_facility: Washington University School of Medicine

location_facility: The University of Arizona Cancer Centre at Dignity Health

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Atlantic Health System / Morristown Medical Center

location_facility: Mayo Clinic Arizona - Mayo Clinic Hospital

location_facility: Hospital Clinic I Provincialde Barcelona

location_facility: Andreas Sygros Hosptial-University of Athen

location_facility: Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

location_facility: Hauttumorcentrum der Charite (HTCC)-Charite Universitatsmedizin Berlin

location_facility: U.O.S.C Di Oncologia Medica E Terapie Innovative

location_facility: New York University School Of Medicine, Kaplan Comprehensive Cancer Center

location_facility: Odette Cancer Center-Sunnybrook Health Sciences Centre

location_facility: National and Kapodistrian University of Athens - School of Health Sciences - Faculty of Medicine

location_facility: University General Hospital of Ioannina - Dermatology and Venereology Department

location_facility: Policlinico S.Orsola-Malpighi U.O. Dermatologia - University of Bologna

title: A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1, in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

design_allocation: Non-Randomized

location_country:
Germany
Italy
Switzerland
Austria
Belgium
United States
Spain
Greece
Canada
France


acronym: STARDUST

lead_sponsor: Janssen-Cilag Ltd.

summary: The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.

ReferenceCitation: Kucharzik T, Wilkens R, D'Agostino MA, Maconi G, Le Bars M, Lahaye M, Bravata I, Nazar M, Ni L, Ercole E, Allocca M, Machkova N, de Voogd FAE, Palmela C, Vaughan R, Maaser C; STARDUST Intestinal Ultrasound study group. Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease. Clin Gastroenterol Hepatol. 2023 Jan;21(1):153-163.e12. doi: 10.1016/j.cgh.2022.05.055. Epub 2022 Jul 14.

evidence: open (via crossref license)

ReferenceCitation: Danese S, Vermeire S, D'Haens G, Panes J, Dignass A, Magro F, Nazar M, Le Bars M, Lahaye M, Ni L, Bravata I, Lavie F, Daperno M, Lukas M, Armuzzi A, Lowenberg M, Gaya DR, Peyrin-Biroulet L; STARDUST study group. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):294-306. doi: 10.1016/S2468-1253(21)00474-X. Epub 2022 Feb 1. Erratum In: Lancet Gastroenterol Hepatol. 2022 Apr;7(4):e8.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Policlinico di Bari Ospedale Giovanni XXIII

location_facility: St George's University Hospital NHS Foundation Trust

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: Azienda Sanitaria Universitaria Integrata di Udine

location_facility: Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

location_facility: Gastroenterology Department GASTROMART s.r.o.

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: Centro Hospitalar Lisboa Central, EPE - Hospital Santo Antonio dos Capuchos

location_facility: County Durham and Darlington NHS Foundation Trust

location_facility: University Hospital in Bratislava, St. Cyril and Method Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Gastroenterology Department ENDOMED, s.r.o.

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

location_facility: Centro Hospitalar e Universitário do Algarve

title: Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

location_country:
Germany
Italy
Portugal
Slovakia
United Kingdom
Denmark
Sweden
Netherlands
Belgium
Spain
Czechia
France


title: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies

acronym: ARCS-Multi

summary:
The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors.

The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas.

Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule).

Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue will also be collected for mesothelin expression testing and biomarker analyses.

ipd_sharing_description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

collaborators:
ImmunoGen, Inc.
MorphoSys AG

sponsor_collaborators:
Bayer
ImmunoGen, Inc.
MorphoSys AG

location_country:
Italy
United Kingdom
Singapore
Australia
Netherlands
Switzerland
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Hospital General Universitario Gregorio Marañón | Oncología

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Clínic i Provincial de Barcelona

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

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

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

location_facility: Washington University School of Medicine


acronym: DARZALEX

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of the study is to compare the overall response rate (ORR) in non-small cell lung cancer (NSCLC) participants treated with daratumumab in combination with atezolizumab versus atezolizumab alone.

sponsor_collaborators:
Janssen Research & Development, LLC
Genentech, Inc.

title: A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination With Atezolizumab Compared With Atezolizumab Alone in Subjects With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

location_country:
Poland
Hungary
United States
Spain
France


acronym: PIONEER 8

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.

ReferenceType: result

ReferenceCitation: Zinman B, Aroda VR, Buse JB, Cariou B, Harris SB, Hoff ST, Pedersen KB, Tarp-Johansen MJ, Araki E; PIONEER 8 Investigators. Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial. Diabetes Care. 2019 Dec;42(12):2262-2271. doi: 10.2337/dc19-0898. Epub 2019 Sep 17.

oa_colors: green other

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

repositories_concat: PubMed Central;fn1074792

publisher_dissemination: American Diabetes Association

ReferenceCitation: Pratley RE, Crowley MJ, Gislum M, Hertz CL, Jensen TB, Khunti K, Mosenzon O, Buse JB. Oral Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Glucose-Lowering Medication: PIONEER Subgroup Analyses. Diabetes Ther. 2021 Apr;12(4):1099-1116. doi: 10.1007/s13300-020-00994-9. Epub 2021 Mar 4.

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repository_institution: Swansea University - Cronfa

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

title: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Insulin. A 52-week, Randomised, Double-blind, Placebo-controlled Trial (PIONEER 8 - Insulin add-on)

location_country:
Poland
India
Japan
Mexico
United States
Greece
Canada
Puerto Rico
Russian Federation
France


acronym: MELTEMI

intervention_type: Biological

lead_sponsor: AstraZeneca

summary: The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).

title: A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)

primary_purpose: Other

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

location_country:
Germany
Poland
United Kingdom
Argentina
Australia
United States
Spain
Turkey
Chile
Czechia
Ukraine
Bulgaria
Canada
Russian Federation
France


title: A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

summary: The purpose of this study is to determine the activity of SY-1425 in relapsed/refractory acute myeloid leukemia (AML) patients (SY-1425 administered as a monotherapy or in combination with azacitidine), relapsed/refractory higher-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy or in combination with daratumumab), newly diagnosed treatment naïve AML patients who are unlikely to tolerate standard intensive chemotherapy (SY-1425 administered as a monotherapy or in combination with azacitidine), or lower-risk myelodysplastic syndrome (MDS) patients (SY-1425 administered as a monotherapy).

lead_sponsor: Syros Pharmaceuticals

location_country:
United States
France

location_facility: Centre Hospitalier de Versailles - Hôpital André Mignot

location_facility: Hôpital Haut Leveque, Centre Francois Magendie

location_facility: Centre Hospitalier Universitiaire Hopital Avicenne

location_facility: Nice Hospital, Archet Hospital 1 Clinical Hematology Service


title: A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

acronym: ExpeditionPRO

summary: The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

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

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Finland
Italy
Poland
United Kingdom
Japan
Sweden
United States
Spain
Taiwan
Canada
Puerto Rico
France

location_facility: University of Texas Health Services Center - Houston

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Rhode Island Mood & Memory Research Institute

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

location_facility: New England Institute for Clinical Research

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Univ of Texas Health Science Center at San Antonio

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: Northeastern Pennsylvania Memory & Alzheimer's Center

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: Johns Hopkins University School of Medicine

location_facility: Dean Foundation for Health Research and Education

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Healthy Perspectives Innovative Mental Health Services, PL

location_facility: Metrolina Neurological Research Institute


title: Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults

summary: The purpose of this study is a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2 additional doses in two subgroups of older adults.

ReferenceCitation: Strezova A, Diez-Domingo J, Al Shawafi K, Tinoco JC, Shi M, Pirrotta P, Mwakingwe-Omari A; Zoster-049 Study Group. Long-term Protection Against Herpes Zoster by the Adjuvanted Recombinant Zoster Vaccine: Interim Efficacy, Immunogenicity, and Safety Results up to 10 Years After Initial Vaccination. Open Forum Infect Dis. 2022 Oct 23;9(10):ofac485. doi: 10.1093/ofid/ofac485. eCollection 2022 Oct.

ReferenceCitation: Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu CJ, Andrews C, Beytout J, Caso C, Cheng HS, Cheong HJ, Choo EJ, Curiac D, Di Paolo E, Dionne M, Eckermann T, Esen M, Ferguson M, Ghesquiere W, Hwang SJ, Avelino-Silva TJ, Kosina P, Liu CS, Markkula J, Moeckesch B, Murta de Oliveira C, Park DW, Pauksens K, Pirrotta P, Plassmann G, Pretswell C, Rombo L, Salaun B, Sanmartin Berglund J, Schenkenberger I, Schwarz T, Shi M, Ukkonen B, Zahaf T, Zerbini C, Schuind A, Cunningham AL; Zoster-049 Study Group. The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster: Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022 Apr 28;74(8):1459-1467. doi: 10.1093/cid/ciab629.

repository_institution: Blekinge Institute of Technology - DiVA

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

repositories_concat: DiVA.org;PubMed Central

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Germany
Italy
United Kingdom
Hong Kong
Australia
Brazil
Japan
Mexico
Sweden
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Estonia
France


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of Pirfenidone

summary: This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
Denmark
Sweden
Austria
Belgium
France


acronym: ARCHES

lead_sponsor: Astellas Pharma Global Development, Inc.

summary: The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.

ReferenceCitation: Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986. doi: 10.1200/JCO.19.00799. Epub 2019 Jul 22.

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

repositories_concat: PubMed Central;diposit.ub.edu

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

ReferenceCitation: Armstrong AJ, Azad AA, Iguchi T, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore ND, Gomez-Veiga F, Rosbrook B, Zohren F, Yamada S, Haas GP, Stenzl A. Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2022 May 20;40(15):1616-1622. doi: 10.1200/JCO.22.00193. Epub 2022 Apr 14.

ReferenceCitation: Stenzl A, Dunshee C, De Giorgi U, Alekseev B, Iguchi T, Szmulewitz RZ, Flaig TW, Tombal B, Morlock R, Ivanescu C, Ramaswamy K, Saad F, Armstrong AJ. Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. Eur Urol. 2020 Oct;78(4):603-614. doi: 10.1016/j.eururo.2020.03.019. Epub 2020 Apr 23.

sponsor_collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

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title: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
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Canada
France
Slovakia
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United States
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel