acronym: A Phase 3 trial of perioperative pembrolizumab for cisplatin-ineligible patients with MIBC

lead_sponsor: Merck Sharp & Dohme LLC

summary:
This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC).

The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone.

With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed.

With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.

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.

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Radboud University - Radboud Repository

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0929)

location_facility: Korea University Anam Hospital ( Site 1351)

location_facility: Hospital Universitario Quiron Madrid ( Site 0694)

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

location_facility: Moncton Hospital - Horizon Health Network ( Site 0112)

location_facility: Lviv State Regional Oncological Center ( Site 0967)

location_facility: Kyungpook National University Chilgok Hospital-Urology ( Site 1357)

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 1001)

location_facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0565)

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

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 1582)

location_facility: Shaare Zedek Medical Center ( Site 0842)

location_facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

location_facility: Medical Sanitary Unit Neftyannik ( Site 0888)

location_facility: MNPE Lviv Regional Clinical Hospital of Lviv Regional Council ( Site 0955)

location_facility: Sunnybrook Research Institute ( Site 0110)

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

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1006)

location_facility: Herlev og Gentofte Hospital. ( Site 0412)

location_facility: Fondazione Salvatore Maugeri IRCCS ( Site 0554)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0921)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1061)

location_facility: Fundación Cardiovascular de Colombia ( Site 2004)

location_facility: University Hospital Waterford ( Site 0747)

location_facility: Regional Oncology Center of Kharkiv ( Site 0958)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 0253)

location_facility: UCL Saint-Luc - Oncologie Medicale ( Site 0357)

location_facility: Kursk Regional Clinical Oncology Dispensary ( Site 0854)

location_facility: Policlinico Gemelli di Roma ( Site 0558)

location_facility: Hospital Universitario San Carlos ( Site 0678)

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

location_facility: Clinic of Bashkortostan State Medical University ( Site 0873)

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

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0535)

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

location_facility: Rigshospitalet University Hospital ( Site 0411)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0845)

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

location_facility: New England Cancer Specialists ( Site 0070)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0549)

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 0548)

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

location_facility: Hospital de Nuestra Senora de Valme ( Site 0693)

location_facility: Seoul National University Hospital ( Site 1352)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0532)

location_facility: Fundación Colombiana de Cancerología Clínica Vida ( Site 2003)

location_facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0675)

location_facility: SNPE National Cancer Institute ( Site 0962)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 2304)

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

location_facility: Greater Baltimore Medical Center ( Site 0014)

location_facility: Western Sydney Local Health District ( Site 1259)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 1058)

location_facility: Aarhus University Hospital Skejby ( Site 0418)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0959)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 0031)

location_facility: Hospital San Pedro de Alcantara ( Site 0697)

location_facility: C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 0492)

location_facility: Kitasato University Hospital ( Site 2306)

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

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 1063)

location_facility: McGill University Health Centre ( Site 0123)

location_facility: Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0528)

location_facility: Klinikum Stuttgart - Katharinenhospital ( Site 0520)

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi ( Site 0924)

location_facility: St. Marianna University Hospital ( Site 2321)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0116)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0254)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 0859)

location_facility: M Health Fairview Ridges Hospital ( Site 1555)

location_facility: Georgetown University Medical Center ( Site 0022)

location_facility: Institut Català d'Oncologia (ICO) - Girona ( Site 0700)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0865)

location_facility: Seoul National University Bundang Hospital ( Site 1356)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 0679)

location_facility: Sakarya Universitesi Tip Fakultesi ( Site 0933)

location_facility: First St. Petersburg State Medical University n.a. acad. I.P. Pavlov ( Site 0872)

location_facility: Hopital Europeen Georges Pompidou ( Site 0476)

location_facility: Abramson Cancer Center of the University of Pennsylvania ( Site 0074)

location_facility: Texas Oncology-Baylor Sammons Cancer Center ( Site 1552)

location_facility: Kyiv City Clinical Oncology Center ( Site 0960)

location_facility: SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 0533)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 0874)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0861)

location_facility: Municipal Non-profit Enterprise of Kharkiv Regional Council RCSDRPP ( Site 0973)

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

location_facility: Bialostockie Centrum Onkologii ( Site 1072)

location_facility: Clinical Research Center Medic-R ( Site 1073)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 1452)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0884)

location_facility: Clinical Hospital Saint Luka ( Site 0867)

location_facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0860)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0926)

location_facility: Tallaght University Hospital ( Site 0734)

location_facility: MNPE V.I. Shapoval Regional Medical Clinical Urology and Nephrology Center of KharkivRegCouncil ( Si

location_facility: Walsall Manor Hospital-Oncology ( Site 0743)

location_facility: Kent and Canterbury Hospital ( Site 0733)

location_facility: Universitaetsklinikum Erlangen ( Site 0546)

location_facility: National Cancer Center Hospital East ( Site 2305)

location_facility: AULSS8 Berica-Ospedale S.Bortolo-ONCOLOGIA CLINICA ( Site 0562)

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 1057)

location_facility: Nara Medical University Hospital ( Site 2312)

location_facility: Charleston Area Medical Center ( Site 0023)

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

location_facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 0878)

location_facility: Kagoshima University Hospital ( Site 2317)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Hospital Clinic i Provincial ( Site 0674)

location_facility: Inova Schar Cancer Institute ( Site 0007)

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

location_facility: Northwell Health- Monter Cancer Center ( Site 0083)

location_facility: Carolina Urologic Research Center ( Site 0062)

location_facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 0121)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0691)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1212)

location_facility: Zhytomyr Regional Oncology Center ( Site 0971)

location_facility: University Malaya Medical Centre ( Site 1702)

location_facility: Thomas Jefferson University ( Site 1579)

location_facility: Centre Georges Francois Leclerc ( Site 0488)

location_facility: Asociación de Beneficencia Hospital Sirio Libanés ( Site 2102)

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

location_facility: Vanderbilt University Medical Center ( Site 0017)

location_facility: Steve Biko Academic Hospital-Medical Oncology ( Site 1601)

location_facility: MNPE City Clinical Hospital #4 of Dnipro Regional Council ( Site 0951)

location_facility: Yitzhak Shamir Medical Center ( Site 0848)

location_facility: Saitama Prefectural Cancer Center ( Site 2319)

location_facility: National University Hospital ( Site 1802)

location_facility: The Royal Marsden Foundation Trust ( Site 0726)

location_facility: Leningrad Regional Oncology Center ( Site 0868)

location_facility: Bon Secours St. Francis Health System ( Site 1572)

location_facility: Providence Portland Medical Center [Portland, OR] ( Site 0095)

location_facility: Azienda Ospedaliera Santa Maria Terni-S.C. Oncologia Medica e Traslazionale ( Site 0564)

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

location_facility: Odense Universitetshospital ( Site 0413)

location_facility: Centro de Tratamiento de Cancer ( Site 0266)

location_facility: Tulane University School of Medicine ( Site 0088)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 1012)

location_facility: Urology Associates [Nashville, TN] ( Site 0053)

location_facility: Imperial College Healthcare NHS Trust ( Site 0745)

location_facility: The James Cook University Hospital ( Site 0730)

location_facility: Tokyo Medical and Dental University Hospital ( Site 2303)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 0561)

location_facility: Hacettepe Universitesi Tıp Fakultesi ( Site 0931)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 1453)

location_facility: ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 0963)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0490)

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

location_facility: Barts Health NHS Trust - St Bartholomew s Hospital ( Site 0725)

location_facility: Hospital Universitario la Paz ( Site 0690)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0841)

location_facility: Hamamatsu University Hospital ( Site 2311)

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

location_facility: Clatterbridge Oncology Centre ( Site 0731)

location_facility: University of Colorado Hospital ( Site 0098)

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

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0930)

location_facility: Nagasaki University Hospital ( Site 2315)

location_facility: Instituto Nacional de Cancerologia. ( Site 0256)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0547)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 0852)

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

location_facility: John H. Stroger Jr. Hospital of Cook County ( Site 1551)

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 0563)

location_facility: St. Joseph Heritage Healthcare ( Site 0046)

location_facility: John Wayne Cancer Institute ( Site 0075)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0486)

title: A Randomized Phase 3 Study Evaluating Cystectomy With Perioperative Pembrolizumab and Cystectomy With Perioperative Enfortumab Vedotin and Pembrolizumab Versus Cystectomy Alone in Participants Who Are Cisplatin-Ineligible or Decline Cisplatin With Muscle-Invasive Bladder Cancer (KEYNOTE-905/EV-303)

type: Registry Identifier

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

collaborators: Astellas Pharma Global Development, Inc.


study_start_date_type: Actual

intervention_type: Drug

acronym: Pan tumor Nivolumab Rollover Study

lead_sponsor: Bristol-Myers Squibb

summary: Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.

location_facility: UW Health - UW Carbone Cancer Center - Medical Oncology Clinic

location_facility: University of Arizona College of Medicine

location_facility: University of Louisville-James Graham Brown Cancer Center

location_facility: Advocate Medical Group - Park Ridge - Luther Ln - Oncology

location_facility: Georgetown-Lombardi Comprehensive Cancer Center

location_facility: Klinikum Kassel - Klinik fuer Haematologie, Onkologie und Immunologie

location_facility: N.N. Blokhin National Medical Research Center of Oncology

location_facility: UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Melanoma Center

location_facility: Public Hospital of King County District 1 Valley Medical Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.

location_facility: Southern District Hospital (SDHB) - Dunedin Hospital

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: University of Michigan Rogel Comprehensive Cancer Center UMCCC

status: Recruiting

title: Pan-Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Non-Randomized

study_completion_date_type: Anticipated

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Romania
Belgium
China
Peru
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND)

acronym: DIAMOND

summary: The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

status: Completed

study_completion_date_type: Actual

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Butler J, Anker SD, Lund LH, Coats AJS, Filippatos G, Siddiqi TJ, Friede T, Fabien V, Kosiborod M, Metra M, Pina IL, Pinto F, Rossignol P, van der Meer P, Bahit C, Belohlavek J, Bohm M, Brugts JJ, Cleland JGF, Ezekowitz J, Bayes-Genis A, Gotsman I, Goudev A, Khintibidze I, Lindenfeld J, Mentz RJ, Merkely B, Montes EC, Mullens W, Nicolau JC, Parkhomenko A, Ponikowski P, Seferovic PM, Senni M, Shlyakhto E, Cohen-Solal A, Szecsody P, Jensen K, Dorigotti F, Weir MR, Pitt B. Patiromer for the management of hyperkalemia in heart failure with reduced ejection fraction: the DIAMOND trial. Eur Heart J. 2022 Nov 1;43(41):4362-4373. doi: 10.1093/eurheartj/ehac401.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: UHasselt - Document Server@UHasselt

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

repository_normalized: HAL

repository_institution: Erasmus University Rotterdam - EUR Research Repository

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

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

publisher_dissemination: Oxford University Press

ReferenceCitation: Bolanos JA, Seliger SL. Recurrent Hyperkalemia in Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Treatment: Stuck between a Rock and a Hard Place. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):345-347. doi: 10.2215/CJN.00950121. Epub 2021 Feb 19. No abstract available.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

ipd_sharing: Yes

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: Vifor Pharma, Inc.

sponsor_collaborators:
Vifor Pharma, Inc.
Syneos Health, LLC

location_country:
Germany
Poland
Argentina
Brazil
Czechia
Canada
Serbia
France
Hungary
United States
Ukraine
Belgium
Italy
United Kingdom
Netherlands
Mexico
Spain
Bulgaria
Georgia
Russian Federation
Israel

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Investigator Site 11-117

status_simplified: Completed


title: Multi-center Cross-sectional Epidemiological Study to Characterize the Prevalence and Distribution of Lipoprotein(a) Levels Among Patients With Established Cardiovascular Disease

summary: The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

primary_purpose: Diagnostic

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Iceland
India
Romania
Lebanon
Belgium
China
Malaysia
Peru
Puerto Rico
Egypt
Philippines
Italy
Guatemala
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

intervention_type: Diagnostic Test


acronym: VESALIUS-CV

lead_sponsor: Amgen

summary: This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.

location_facility: Instituto Medico DAMIC - Fundacion Rusculleda

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: Multicare Institute for Research and Innovation

location_facility: SBHI Medical and sports dispensary of Krasnogvardeisky district of Saint Petersburg

location_facility: Unidade Local de Saude de Matosinhos - Hospital Pedro Hispano

location_facility: University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Center for Clinical Trials of Sacramento Inc

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Saint Petersburg State Budget Healthcare Institution Pokrovskaya City Hospital

location_facility: Cardiology Consultants of Philadelphia CCP

location_facility: University Hospitals of Derby and Burton NHS Foundation Trust

location_facility: Centre intégré de santé et de services sociaux (CISSS) des Laurentides - Unité de recherche clini

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Kardiologijos ir reabilitacijos klinika, UAB

location_facility: Miedziowe Centrum Zdrowia Spolka Akcyjna

location_facility: Deutsches Herzzentrum München des Freistaates Bayern

location_facility: BHI of Republic Udmurtiya City clinical hospital 9 of Ministry of healthcare of Republic Udmurtiya

location_facility: Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

location_facility: Multiprofile Regional Hospital for Active Treatment Dr Stefan Cherkezov AD

location_facility: Center for Clinical and Basic Research Aalborg

location_facility: Communal Healthcare Institution Kharkiv City Clinical Hospital No27

location_facility: LaPorte County Institute for Clinical Research

location_facility: University of North Carolina at Chapel Hill

location_facility: Policlinico Universitario Campus Biomedico

location_facility: Cardiovascular Research Center of South Florida

location_facility: Centre Hospitalier Universitair Ambroise Pare

location_facility: Podhalanski Szpital Specjalistyczny im Jana Pawla II w Nowym Targu

location_facility: Highlands Clinical Research Facility, Raigmore Hospital

location_facility: FSBI Heart and Vessels Diseases complex problems Scientific Research Institution

location_facility: Private Small Enterprise, Medical Center Pulse

location_facility: Northern Light Eastern Maine Medical Center

location_facility: Treant Zorggroep, locatie Scheper ziekenhuis Emmen

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Samodzielny Publiczny Specjalistyczny Szpital Zachodni im swietego Jana Pawla II

location_facility: The University of Iowa College of Public Health

location_facility: Regional Budget Healthcare Institution Cardiology Dispensary

location_facility: Samara Regional Clinical Cardiology Dispensary

location_facility: NSHI Departmental Hospital at the station Barnaul of OJSC Russian Railways

location_facility: Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika

location_facility: Communal Non-commercial enterprise "City Hospital #6 "of Zaporizhzhia City Council

location_facility: Regional State Budget Helthcare Institution Smolensk Regional Clinical Hospital

location_facility: Papageorgiou General Hospital of Thessaloniki

location_facility: Central City Clinical Hospital 1 of the Oktyabrsky District

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Specialty Hospital for Active treatment in Cardiology Sveti Georgi - Pernik OOD

location_facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

location_facility: Kardio Vaclavik sro, Interni a kardiologicka ambulance

location_facility: IBPClin Instituto Brasil de Pesquisa Clinica

location_facility: Zespol Przychodni Specjalistycznych Diab-End-Cor Sp z oo

location_facility: State Budgetary Health Institution City Hospital 4 of the City of Sochi

location_facility: Instituto de Investigaciones Clinicas Mar del Plata

location_facility: Centro de Estudios Clinicos de Queretaro

location_facility: SBHI of Moscow City clinical hospital 64 of Moscow Healthcare department

location_facility: University of Colorado Memorial Health System

location_facility: Instituto de Investigaciones Clinicas Zarate

location_facility: Multiprofile Hospital for Active Treatment- Medical Complex- Sveti Ivan Rilski EOOD

location_facility: Centro de Especialidades Medicas - Cemedic

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Novant Health Heart and Vascular Institute

location_facility: Saint Petersburg State Budget Healthcare Institution City Polyclinic 109

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Onze Lieve Vrouw Ziekenhuis - campus Aalst

location_facility: Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Dr Lakatos Ferenc Private Cardiology Practice

location_facility: Clinical Best Solutions Sp zoo Spolka komandytowa

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Center for Clinical and Basic Research Tallinn

location_facility: Medinova South London Dedicated Research Centre

location_facility: State Budget Institution of Ryazan Region Regional Clinical Hospital

location_facility: State Budget Medical Institution Sverdlovsk Regional Clinical Hospital N1

location_facility: Medinova Northamptonshire Dedicated Research Site

location_facility: South Texas Cardiovascular Consultants PLLC

location_facility: Saint Petersburg SBHI City Hospital 38 named after N A Semashko

location_facility: Kirov Regional State Budget Healthcare Institution Kirov City Clinical Hospital 1

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: prof MUDr Lubomir Elbl, CSc, Kardiologicka ambulance

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Puc Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da Pucpr/Epicenter

location_facility: Piedmont Medical Group Research of Rocky Mount

location_facility: Instituto de Cardiologia de Corrientes Juana Francisca Cabral

location_facility: Hospital Universitario Fundacion Favaloro

location_facility: Benedor sro - Kardiologicka, cevni a interni ambulance

location_facility: Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu",

location_facility: Adelaide Cardiology Practice - Leabrook Clinic

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada SC

location_facility: Wojewodzki Specjalistyczny Szpital im dr Wladyslawa Bieganskiego w Lodzi

location_facility: Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum

location_facility: Northwell Health Physician Partners Cardiology

location_facility: National Scientific Center "M.D. Strazhesko Institute of Cardiology"

location_facility: National Medical Research Center for therapy and preventive medicine

location_facility: Cardresearch Cardiologia Assistencial de Pesquisa

location_facility: Specjalistyczna Poradnia Kardiologiczna i Nadcisnienia Tetniczego Beata Wozakowska-Kaplon

location_facility: Nebraska Western Iowa Health Care System

location_facility: State Autonomous Healthcare Institution of the Tyumen region Medical Scientific Practical Center

location_facility: Vinnytsia M I Pyrogov Regional Clinical Hospital Vinnytsia M I Pyrogov National Medical University

location_facility: Dr T G Elliott Incorporated - BC Diabetes

location_facility: Kardiologicke centrum MUDr Janky Skrobakove sro

location_facility: Fondazione Toscana Gabriele Monasterio Ospedale del Cuore G Pasquinucci

location_facility: Regional Clinical Hospital 2 of the Ministry of Health Krasnodar region

location_facility: University of Florida and Shands Hospital

location_facility: Clinical Mayo de Urgencias Medicas Cruz Blanca SRL

location_facility: Hospital Clinico Universitario de Valencia

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

location_facility: Multiprofile Hospital for Active Treatment Sveta Anna Sofia AD

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Balatonmariafurdo Kozseg Onkormanyzatanak Haziorvosi Rendeloje

location_facility: Metropolitan Cardiovascular Consultants LLC

location_facility: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu

location_facility: Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet

location_facility: SBHI of Vladimirskaya region City Hospital 4 of Vladimir

location_facility: Dace Teterovska Doctor Practice in Endocrinology

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

location_facility: Ambulatory for special outpatient medical aid in Cardiology-Private Practice Dr Elena Dotcheva EOOD

location_facility: Universitaets-Herzzentrum Freiburg - Bad Krozingen

location_facility: Curtin University Centre of Clinical Research and Education

location_facility: Tribe Clinical Research LLC DBA Mountain View Clinical Research

location_facility: Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone

location_facility: Institut de recherches cliniques de Montreal

location_facility: Cinme - Centro de Investigaciones Metabolicas

location_facility: Medinova North London Dedicated Research Centre

location_facility: National Multiprofile Transport Hospital Tzar Boris III

location_facility: Center for Clinical Research Pardubice, sro

location_facility: Praxispont Belvarosi Maganegeszsegugyi Kozpont

location_facility: Multiprofile Hospital for Active Treatment - Haskovo AD

location_facility: Hudson Valley Cardiovascular Physicians PC

location_facility: Moscow SBHI City Clinical Hospital 15 n a O M Filatov of Moscow Healthcare Department

location_facility: Vilnius University Hospital Santaros Clinic Public Institution

location_facility: FSBSI Scientific Research Institute of Therapy and preventive medicine

location_facility: Diagnostic-Consultative Center Convex EOOD

location_facility: Harbor University of California Los Angeles Medical Center

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: My Endo Diabetes and Endocrinology Center

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Associacao Protectora dos Diabeticos de Portugal

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon

location_facility: Clinique des Maladies Lipidiques de Quebec Incorporated

location_facility: LMC Clinical Research Incorporated Thornhill

location_facility: University Hospitals Cleveland Medical Center

location_facility: Ordensklinikum Linz Barmherzige Schwestern

location_facility: North York Diagnostic and Cardiac Centre

location_facility: Szpital Uniwersytecki nr 1 im dr Antoniego Jurasza w Bydgoszczy

location_facility: Centrum Szybkiej Diagnostyki Kardiologicznej Kardiomed M Zabowka E Zabowka Spolka cywilna

location_facility: Zentrum fuer klinische Studien - Dr Hanusch GmbH

location_facility: CARINTART Sp zoo Krakowskie Centrum Diagnostyczno-Kliniczne

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: The Catholic University of Korea Seoul St Marys Hospital

location_facility: FSBI Russian Cardiology Research and Production Complex

location_facility: Centre Hospitalier de Pau - Hopital Francois Mitterrand

location_facility: North Shore Diabetes and Endocrine Associates

location_facility: Cardiovascular Research Foundation of Southern California

location_facility: MeDiNova Warwickshire Quality Research Site

location_facility: Spitalul Clinic Universitar de Urgenta Elias

location_facility: Almazov National Medical Research Centre

location_facility: Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Communal Noncommercial Institution Consultative and Diagnostic Center of Desnianskyi District of Kyi

location_facility: Intercard Spzoo Centrum Kardiologii Inwazyjnej Elektroterapii i Angiologii w Krosnie

location_facility: Texas Institute for Kidney and Endocrine Disorders

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Medinova East London Dedicated Research Centre

location_facility: Instituto de Investigaciones Clínicas Rosario-Sanatorio Delta

location_facility: Centre Hospitalier Universitaire de Nantes - Hopital Guillaume et Rene Laennec

location_facility: University Multiprofile Hospital for Active Treatment and Emergency Medicine N I Pirogov EAD

location_facility: Icba - Instituto Cardiovascular de Buenos Aires

location_facility: Division of Cardiovascular Research at Peconic Bay Medical Center

location_facility: Tomasz Blicharski Lubelskie Centrum Diagnostyczne

location_facility: Centro Hospitalar do Baixo Vouga, EPE - Hospital Infante Dom Pedro

location_facility: Diabetologische Gemeinschaftspraxis Dr Schaper und Dr Faulmann

location_facility: SMH Cardiology Clinical Trials Incorporated

location_facility: Centre Hospitalier Universitaire de Nice - Hopital Pasteur

location_facility: Medizinisches Versorgungszentrum im Altstadt-Carree Fulda

location_facility: Narodny ustav srdcovych a cievnych chorob, as

location_facility: Center for Clinical and Basic Research Vejle

location_facility: Medical Center for Specialized Medical Care of Cardiovascular Diseases OOD

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Wegrowie

location_facility: Centrum Medyczne Pulawska spzoo Centrum Medyczne Pulawska NZOZ

location_facility: Centro de Investigaciones Clinicas del Litoral

location_facility: Westside Medical Associates of Los Angeles

location_facility: Centro Hospitalar e Universitario de Coimbra EPE

location_facility: Cardiology Associates of Fairfield County, PC

location_facility: Kyiv City Clinical Emergency Medical Care Hospital

location_facility: Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: McGill University Health Centre - Montreal General Hospital

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik III

location_facility: Instituto de Investigaciones Clinicas Bahia Blanca

location_facility: Centrum Kardiologiczne Pro Corde Spzoo Centrum Kardiologicne Pro Corde Wroclaw

location_facility: Zakarpattia Oblast Clinical Center of Cardiology and Cardio Surgery

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

location_facility: Northwell Health Lenox Hill Heart and Vascular

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

location_facility: Regional State Budget Health care Institution Altay Regional Cardiology Dispensary

location_facility: Hospices Civils de Lyon Groupement Hospitalier Est, Hopital Louis Pradel

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

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

location_facility: Oleksandrivska Clinical Hospital of Kyiv

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Medical and Sanitary Unit of Open Joint Stock Company Kharkiv Tractor Plant

location_facility: Centro de investigacion Cardiometabolica

location_facility: Jacksonville Center for Clinical Research

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

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

location_facility: Albert Schweitzer Ziekenhuis, Locatie Dordwijk

location_facility: Azienda Ospedaliero Universitaria Integrata di Udine

location_facility: Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek Henryk Rudzki spolka jawna

location_facility: Instituto de Investigaciones Metabolicas - Idim

location_facility: Centre for Clinical and Basic Research Ballerup

location_facility: MeDiNova West London Quality Research Site

location_facility: Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

location_facility: Clinical Best Solutions Sp zoo Spolka komandytowa Gabinet Lekarski

location_facility: Marek Piepiorka Gabinet Kardiologiczno-Internistyczny

location_facility: I Medizinische Klinik Gesundheitsverbund Landkreis Konstanz

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: Konstantopoulio - Agia Olga Hospital of Nea Ionia

location_facility: Western Centre for Public Health and Family Medicine - Western University

location_facility: Kardiologisch - Angiologische Praxis - Herzzentrum Bremen

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Szpital Grochowski imienia Doktora medycyny Rafala Masztaka Spzoo

location_facility: WMCHealth Heart and Vascular Institute Kingston Division of Cardiology

location_facility: Centre Hospitalier Universitaire Amiens - Hopital Sud

location_facility: Instituto de Pesquisa Clinica de Campinas

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: Albert Schweitzer Ziekenhuis location Dordwijk

location_facility: NZOZ Specjalistyczna Przychodnia Lekarska Medikard

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: First City Clinical Hospital na E E Volosevich

location_facility: Fundaçao Hospitalar Sao Francisco de Assis

location_facility: American Heart of Poland Sa Malopolskie Centrum Sercowo-Naczyniowe PAKS - Chrzanow

location_facility: Futuremeds spolka z ograniczona odpowiedzialnoscia

location_facility: SBHI Scientific Research Institute Regional Clinical Hospital 1 named after S V Ochapovsky

location_facility: Bluewater Clinical Research Group Incorporated

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Nemocnice Pardubickeho kraje as, Svitavska nemocnice

location_facility: Presidio Ospedaliero Santa Maria delle Grazie

location_facility: Centre Hospitalier Regional Universitaire de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Centre Hospitalier Universitaire de Dijon - Hopital Francois Mitterrand

location_facility: Jellinger and Lerman MD PA dba The Center for Diabetes and Endocrine Care

location_facility: Seoul National University Bundang Hospital

location_facility: KO-MED Centra Kliniczne Spzoo KO-MED Centra Kliniczne Pulawy

location_facility: Centro de Pesquisas em Diabetes e Doencas Endocrino Metabolicas

location_facility: Instituto de Investigaciones Clinicas de San Nicolas

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej w Lecznej

location_facility: City Clinical Hospital named after Zhadkevich

location_facility: Ciprec - Centro de Investigacion y Prevencion Cardiovascular

location_facility: Clinical Best Solutions Spolka z ograniczona odpowiedzialnoscia Spolka komandytowa

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Ciad - Consultorio Integral de Atencion al Diabetico

location_facility: MUDr Zbynek Kosek, kardiologicka ambulance sro

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: SBHI of Novosibirsk Region City clinical hospital 1

location_facility: Hamilton Health Sciences Hamilton General Hospital

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: State Institution National Scientific Center Acad MD Strazhesko Institute of cardiology of NAMS Ukr

location_facility: KO-MED Centra Kliniczne Spzoo KO-MED Centra Kliniczne Staszow

location_facility: State Institution National Scientific Center Acad Strazhesko Institute of Cardiology

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

location_facility: Budget Healthcare Institution of Omsk region Medical-sanitary unit 9

location_facility: Clinical Hospital named after S R Mirotvortsev

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Communal Noncommercial enterprise "City Hospital #8" of Kharkiv City Council

location_facility: SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed S.R.L

location_facility: Ivano-Frankivsk Regional Clinical Cardiology Center of Ivano-Frankivsk Regional Council

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

location_facility: Ewa Mirek-Bryniarska Specjalistyczna Praktyka Lekarska

location_facility: Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

location_facility: Fifth Multiprofile Hospital for Active Treatment - Sofia EAD

location_facility: MUDr Ladislava Harrerova, kardiologicka ordinace

location_facility: Applied Medical Informatics Research Incorporated

location_facility: KO-MED Centra Kliniczne Spzoo KO-MED Centra Kliniczne Zamosc

location_facility: Hospital da Senhora da Oliveira, Guimaraes, EPE

location_facility: SBHI of Nizhny Novgorod region Nizhny Novgorod regional clinical hospital na N A Semashko

location_facility: Heart Health Institute Research Incorporated

location_facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa

status: Active, not recruiting

title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

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

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Iceland
Ukraine
Romania
Belgium
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Sweden


type: Other Identifier

title: Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer

summary: The purpose of this study is to evaluate the prevalence of 4 or more DNA-repair gene defects in a population of men with metastatic Prostate Cancer (PC) and to use the reported DNA-repair gene defects to assess biomarker eligibility for niraparib interventional studies.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Canada
France
Belarus
Denmark
United States
Ukraine
Belgium
Malaysia
Italy
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: State Institution N.N. Alexandrov Republican Scientific and

location_facility: Medradius Clinica de Medicina Nuclear e Radiologia de Maceio Ltda.

location_facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

location_facility: Southern Alberta Institute of Urology / Prostate Cancer Centre

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

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

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Azienda ULSS 3 Serenissima, presidio di Mirano

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia

location_facility: PP.OO. di Piombino e Portoferraio Azienda USL Toscana nord ovest

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Klinikum Region Hannover Klinikum Siloah

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Bobruisk Interregional Oncological Dispensary

location_facility: ME 'Poltava Regional Clinical Hospital n.a. M.V. Sklifosovsky of the Poltava Regional Council'

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Pyatigorsk Interdistrict Oncology Dispensary

location_facility: Urologische Gemeinschaftspraxis Böhm/Linne - Germany

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Azienda Ulss 6 Euganea- Ospedale Di Camposampiero

location_facility: Beth Israel Deaconess Hospital Plymouth, Jordan Club Cancer Center

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Azienda ULSS5 Polesana di Rovigo - Ospedale Santa Maria della Misericordia

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Frederick Health Hospital - James M Stockman Cancer Institute

location_facility: Specjalistyczna przychodnia lekarska POLIMED

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

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

location_facility: CUROS - Uberörtliche urologische Gemeinschaftspraxis

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: Communal Nonprofit Enterprise 'Regional Clinical Oncology Center of Kirovohrad Regional Council'

location_facility: Texas Oncology Deke Slayton Cancer Center

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

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

location_facility: District Oncology Dispensary with In-Patient Stationary - Plovdiv

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Sociedade Beneficente de Senhoras - Hospital Sirio Libanes HSL Unidade Brasilia

location_facility: Suporte Nutricional e Quimioterapia Ltda-Pronutrir

location_facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Centre Hospitalier Regional Universitaire Besancon

location_facility: Sakarya University Training and Research Hospital

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: uro Eimsbüttel - Gemeinschaftspraxis Bath/Weinzierl

location_facility: Hôpitaux Universitaire de Strasbourg -CHU

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Cancer Centre of Southeastern Ontario (Kingston Regional Cancer Centre)

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Centers for Advanced Urology LLC d b a MidLantic Urology

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Urologie im Schlosscarree Schreier/Eichler/Junius - Germany

location_facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach

location_facility: Eastern Connecticut Hematology & Oncology Assoc.

location_facility: Centre hospitalier universitaire de Québec (CHUQ), L'Hotel-Dieu de Quebéc

location_facility: Universidade do Estado do Rio de Janeiro - UERJ

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: Adult Pediatric Urology & Urogynecology, P.C

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Seoul National University Bundang Hospital

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: British Columbia Cancer Agency (BCCA) - Vancouver Centre

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

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

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

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

intervention_type: Other


lead_sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

summary: AML and MDS-EB2 are malignancies of the bone marrow. The standard treatment for these diseases is chemotherapy. Patients participating have a special type of this disease because the leukemia cells (blasts) have developed an error in the genetic material (DNA). This error is called an IDH1 mutation or an IDH2 mutation (a mutation is a change in the DNA), which leads to changes in specific substances in the leukemia cells. This trial will investigate whether the addition of the new drugs Ivosidenib (for patients with IDH1 mutation) or Enasidenib (for patients with IDH2 mutation) to the standard treatment of chemotherapy controle the disease more effectively and for a longer period.

sponsor_collaborators: Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)

location_facility:
DE-Berlin-CAMPUSVIRCHOW
BE-Brussel-BORDET
FR-Rennes cedex 9-CHURENNES
SE-Stockholm-KAROLINSKAHUDDINGE
AU-Melbourne-MONASH
CH-Basel-USB
FR-Nice-CAL
NO-Bergen-HELSEBERGEN
FI-Helsinki-HUS
DE-Oldenburg-KLINIKUMOLDENBURG
DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
AU-Brisbane-PAH
DE-Ulm-UNIKLINKULM
LU-Luxembourg-CHL
NL-Breda-AMPHIA
DE-Hamburg-ASKLEPIOSSTGEORG
NL-Den Haag-HAGA
NL-Nijmegen-RADBOUDUMC
ES-Barcelona-VHEBRON
FR-Clamart-HIAPERCY
DE-Magdeburg-OVGU
AU-Perth-RPH
BE-Yvoir-MONTGODINNE
DE-Offenburg-ORTENAUKLINIKUM
NO-Oslo-OSLOUH
NL-Maastricht-MUMC
DE-Düsseldorf-MEDUNIDUESSELDORF
DE-Wuppertal-HELIOSGESUNDHEIT
NO-Tromsø-NORTHNOORWEGEN
FR-Paris cedex 12-SAINTANTOINE
DE-Berlin-VIVANTESURBAN
ES-Tarragona-JOAN
FR-Tours cedex-BRETONNEAU
CH-Luzern-LUKS
FR-Rouen cedex-BECQUEREL
NL-Dordrecht-ASZ
NL-Delft-RDGG
FR-Montpellier-STELOI
DE-Bonn-UNIBONN
DE-Lemgo-KLINIKUMLIPPE
IE-Cork-CUH
FR-Lyon Pierre Benite cedex-LYONSUD
SE-Uppsala-UPPSALAUH
DE-Luedenscheid-KLINIKUMLUEDENSCHEID
AU-Adelaide-RAH
CH-Zürich-USZ
BE-Roeselare-AZDELTA
AT-Innsbruck-IMED
NL-Amersfoort-MEANDERMC
FR-Reims-CHREIMS
DE-Esslingen-KLINIKUMESSLINGEN
FR-Angers-CHUANGERS
AU-Sydney-SVHS
FR-Nice-LARCHET
BE-Brugge-AZBRUGGE
DE-Hamm-EVKHAMM
NL-Utrecht-UMCUTRECHT
NL-Leeuwarden-MCL
DE-Tübingen-MEDUNITUEBINGEN
DE-Meschede-HOCHSAUERLAND
FR-Grenoble cedex 9-CHUGRENOBLE
NL-Den Bosch-JBZ
FR-Mulhouse-GHRMSA
DE-Hannover-MHHANNOVER
DE-Dortmund-JOHODORTMUND
AU-Camperdown-RPA
AU-Launceston TAS-LAUNCESTON
DE-Ludwigshafen-KLILU
ES-Barcelona-CLINICUB
AU-Perth-FSH
EE-Tartu-TARTU
DE-Stuttgart-DIAKSTUTTGART
DE-Traunstein-TSSOB
IE-Dublin 9-BEAUMONT
DE-Passau-KLINIKUMPASSAU
BE-Gent-UZGENT
NL-Enschede-MST
FR-Vandoeuvre Les Nancy-CHRUNANCY
DE-Bremen-KBM
FR-Pessac Cedex-CHUBORDEAUX
BE-Antwerpen-ZNASTUIVENBERG
FR-Amiens-CHUAMIENS
DE-Berlin-CAMPUSBENFRANKLIN
FR-Argenteuil-CHARGENTEUIL
DE-München-IRZTUM
ES-Barcelona-ICODURANREYNALS
DE-Minden-MUEHLENKREISKLINKEN
DE-Mainz-KLINKUNIMAINZ
FR-Chambery-CHMETROPOLESAVOIE
DE-Villingen-Schwenningen-SBKVS
BE-Bruxelles-STLUC
DE-Hamburg-ASKLEPIOS
DE-Herne-MARIENHOSPITALHERNE
NL-Nieuwegein-ANTONIUS
NL-Eindhoven-MAXIMAMC
CH-Bern-INSEL
DE-Essen-KEM
DE-Bad Saarow-HELIOSBADSAAROW
AU-Melbourne-AUSTIN
FR-Toulouse-CHUTOULOUSE
DE-Goch-KKLE
FR-Besançon Cedex-JEANMINJOZ
ES-Barcelona-SANTPAU
DE-Homburg-UNIKLINIKSAARLAND
FR-Marseille-IPC
FR-Lyon-LEONBERARD
FR-Créteil cedex-CHUMONDOR
BE-Brussel-UZBRUSSEL
DE-Trier-MUTTERHAUS
FR-Clermont-Ferrand-ESTAING
ES-Madrid-CSGREGORIOMARANON
NL-Rotterdam-ErasmusMC
CH-Bellinzona-IOSI
DE-Karlsruhe-KLINIKUMKARLSRUHE
NL-Amsterdam-VUMC
FR-Lille-CHULILLE
DE-Lebach-CARITASKHLEBACH
DE-Stuttgart-KLINIKUMSTUTTGART
FR-Villejuif-GUSTAVEROUSSY
BE-Haine-Saint-Paul-JOLIMONT
FI-Tampere-TAYS
NO-Stavanger-HELSESTAVANGER
BE-Liege-CHRCITADELLE
NL-Zwolle-ISALA
BE-Hasselt-VIRGAJESSE
ES-Palma-SSIB
AT-Graz-MEDUNIGRAZ
NL-Amsterdam-OLVG
ES-Valencia-MALVARROSA
AU-Hobart TAS-RHOBART
AU-Sydney-WSAH
DE-Hamburg-UKE
NL-Leiden-LUMC
AU-Melbourne-SVHM
DE-Giessen-UKGM
NO-Trondheim-STOLAV
CH-Fribourg-HFR
AU-Sydney-CONCORD
IE-Galway-UHGALWAY
AU-Douglas-TOWNSVILLE
AU-Adelaide-FLINDERS
AU-Melbourne-RMELBOURNE
CH-St. Gallen-KSSG
ES-Barcelona-PARCDESALUTMAR
CH-Lausanne-CHUV
AU-Perth-SCGH
ES-Barcelona-GERMANTRIALS
NL-Amsterdam-AMC
DE-Flensburg-MALTESER
CH-Geneve (14)-HCUGE
NL-Arnhem-RIJNSTATE
NL-Groningen-UMCG
ES-Barcelona-MUTUATERRASSA
AU-Canberra-CANBERRAHOSPITAL
AT-Vienna-HANUSCH
IE-Dublin 8-STJAMES
FR-Limoges-CHULIMOGES
AU-Melbourne-ALFRED
FR-Orléans-CHORLEANS
DE-Mainz-UNIMEDIZINMAINZ
FR-Strasbourg cedex-HAUTEPIERRE
AT-Linz-ORDENSKLINIKUM
BE-Leuven-UZLEUVEN
ES-Girona-ICSTRUETA
DE-Bochum-RUB
DE-München-MEDUNIMUNCHIN
FR-Nantes-CHUNANTES
BE-Liege-CHULIEGE
FR-Lens-CHLENS
AU-Sydney-RNSH
LT-Vilnius-SANTA
DE-Hanau-KLINIKUMHANAU
DE-Berlin-VIVANTESNEUKOLLN
FR-Bobigny-AVICENNE
SE-Lund-SUH
FR-Le Chesnay cedex-CHVERSAILLES
FR-Bayonne-CHCOTEBASQUE
FR-Paris cedex 15-NECKER
DE-Hannover-SILOAHKRH
AU-Waratah-CALVARYMATER
FR-Poitiers-CHUPOITERS
FR-Paris cedex 10-SAINTLOUIS

title: A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy.

location_country: Finland Germany Ireland Lithuania Norway Australia Sweden Netherlands Austria Belgium Switzerland Spain Luxembourg Estonia France


title: A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)

summary:
The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.

The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to:

Overall Survival (OS) and
Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR)

As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected.

ReferenceType: result

ReferenceCitation: Antonarakis ES, Park SH, Goh JC, Shin SJ, Lee JL, Mehra N, McDermott R, Sala-Gonzalez N, Fong PC, Greil R, Retz M, Sade JP, Yanez P, Huang YH, Begbie SD, Gafanov RA, De Santis M, Rosenbaum E, Kolinsky MP, Rey F, Chiu KY, Roubaud G, Kramer G, Sumitomo M, Massari F, Suzuki H, Qiu P, Zhang J, Kim J, Poehlein CH, Yu EY. Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial. J Clin Oncol. 2023 Aug 1;41(22):3839-3850. doi: 10.1200/JCO.23.00233. Epub 2023 Jun 8.

location_country:
Germany
Ireland
New Zealand
Argentina
Australia
Brazil
Japan
Chile
Canada
France
United States
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Policlinico S.Orsola-Malpighi ( Site 0453)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0337)

location_facility: Seattle Cancer Care Alliance ( Site 0079)

location_facility: Nebraska Cancer Specialists ( Site 0034)

location_facility: Centre D Oncologie de Gentilly ( Site 0432)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0430)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)

location_facility: Yamaguchi University Hospital ( Site 0717)

location_facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)

location_facility: Royal Brisbane and Women s Hospital ( Site 0155)

location_facility: John Flynn Hospital & Medical Centre ( Site 0164)

location_facility: Taipei Veterans General Hospital ( Site 0135)

location_facility: Toho University Sakura Medical Center ( Site 0703)

location_facility: Medizinische Universitat Graz ( Site 0374)

location_facility: St. Vincent Frontier Cancer Center ( Site 0016)

location_facility: Instituto Medico Alexander Fleming ( Site 1010)

location_facility: Osaka International Cancer Institute ( Site 0722)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

location_facility: Port Macquarie Base Hospital ( Site 0153)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0441)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 0463)

location_facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0330)

location_facility: Vrije Universiteit Medisch Centrum ( Site 0479)

location_facility: Beth Israel Deaconess Medical Ctr. ( Site 0093)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)

location_facility: Hospital de Caridade de Ijui ( Site 1038)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 0077)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301)

location_facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

location_facility: Instituto de Investigaciones Metabolicas ( Site 1011)

location_facility: Presidio Ospedaliero Santa Chiara ( Site 0451)

location_facility: Institut Mutualiste Montsouris ( Site 0446)

location_facility: National Taiwan University Hospital ( Site 0131)

location_facility: University of Miyazaki Hospital ( Site 0721)

location_facility: University Hospitals of Cleveland Seidman Cancer Center ( Site 0036)

location_facility: Froedtert and Medical College of Wisconsin ( Site 0045)

location_facility: China Medical University Hospital ( Site 0132)

location_facility: Saitama Medical University International Medical Center ( Site 0708)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 0559)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113)

location_facility: Medizinische Universitaet Wien ( Site 0375)

location_facility: Yokohama City University Medical Center ( Site 0706)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1041)

location_facility: Franciscus Gasthuis en Vlietland ( Site 0489)

location_facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

location_facility: Nagasaki University Hospital ( Site 0719)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0114)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0546)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0081)

location_facility: Fundacion Arturo Lopez Perez ( Site 1049)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0540)

location_facility: Georgia Cancer Center at Augusta University ( Site 0026)

location_facility: Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579)

location_facility: Kobe City Medical Center General Hospital ( Site 0726)

location_facility: Southern Medical Day Care Centre ( Site 0160)

location_facility: Institut De Cancerologie De L Ouest ( Site 0448)

location_facility: Tallaght University Hospital ( Site 0730)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

location_facility: Central Clinical Hospital with Polyclinic ( Site 0562)

location_facility: National Cheng Kung University Hospital ( Site 0134)

location_facility: Radboud University Medical Center ( Site 0470)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)

location_facility: The Urology Group- Cincinnati ( Site 0094)

location_facility: Hospital Britanico de Buenos Aires ( Site 1006)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0568)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0334)

location_facility: UMass Memorial Medical Center ( Site 0053)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)

location_facility: Chonnam National University Hwasun Hospital ( Site 0174)

location_facility: University of New Mexico Cancer Center ( Site 0048)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Kanazawa University Hospital ( Site 0701)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0092)

location_facility: Carolina Urologic Research Center ( Site 0070)

location_facility: Fujita Health University Hospital ( Site 0724)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 0458)

location_facility: Associated Medical Professionals of NY ( Site 0060)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)

location_facility: Institut Regional du Cancer de Montpellier - ICM ( Site 0443)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)

location_facility: St. Joseph Heritage Healthcare ( Site 0069)

location_facility: Hospital San Pedro de Alcantara ( Site 0326)

location_facility: Chesapeake Urology Research Associates ( Site 0076)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040)

location_facility: Centro de Diagnostico Urologico ( Site 1008)

location_facility: Nippon Medical School Hospital ( Site 0709)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0121)

location_facility: Gabrail Cancer Center-Research ( Site 0097)

location_facility: University of North Midlands NHS Foundation Trust ( Site 0527)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)

location_facility: Haaglanden MC - locatie Antoniushove ( Site 0471)

location_facility: Universitaetsklinikum Erlangen ( Site 0303)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0306)

location_facility: Universitaetsklinikum in Mannheim ( Site 0314)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013)

location_facility: Peter MacCallum Cancer Centre ( Site 0152)

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462)

location_facility: Medical Oncology Ospedale San Donato ( Site 0461)

location_facility: Taichung Veterans General Hospital ( Site 0133)

location_facility: Kitasato University Hospital ( Site 0705)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)

location_facility: SBHI Leningrad Regional Oncology Dispensary ( Site 0588)

location_facility: Nara Medical University Hospital ( Site 0715)

location_facility: Universitaetsklinik fuer Urologie ( Site 0307)

location_facility: Hamamatsu University Hospital ( Site 0720)

location_facility: National Cancer Center Hospital East ( Site 0702)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0716)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1047)

location_facility: Dana Farber Cancer Institute ( Site 0033)

location_facility: Severance Hospital Yonsei University Health System ( Site 0173)


acronym: Phase 3 Study of Pembrolizumab plus Docetaxel in mCRPC

summary:
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).

There are two primary study hypotheses.

Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).

Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.

ReferenceCitation: Petrylak DP, Ratta R, Gafanov R, Facchini G, Piulats JM, Kramer G, Flaig TW, Chandana SR, Li B, Burgents J, Fizazi K. KEYNOTE-921: Phase III study of pembrolizumab plus docetaxel for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Sep;17(25):3291-3299. doi: 10.2217/fon-2020-1133. Epub 2021 Jun 8.

oa_host_type: publisher

repositories_concat: closed

location_facility: University of Colorado Cancer Center ( Site 0022)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 0337)

location_facility: Nebraska Cancer Specialists ( Site 0034)

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309)

location_facility: Centre D Oncologie de Gentilly ( Site 0432)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0430)

location_facility: The Fifth Medical Center of PLA General Hospital ( Site 1307)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105)

location_facility: Yamaguchi University Hospital ( Site 0717)

location_facility: CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102)

location_facility: John Flynn Hospital & Medical Centre ( Site 0164)

location_facility: Taipei Veterans General Hospital ( Site 0135)

location_facility: National Medical Research Radiological Center ( Site 0556)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 0336)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0322)

location_facility: Toho University Sakura Medical Center ( Site 0703)

location_facility: Medizinische Universitat Graz ( Site 0374)

location_facility: Zhongshan Hospital Fudan University ( Site 1301)

location_facility: St. Vincent Frontier Cancer Center ( Site 0016)

location_facility: Centro de Investigaciones Clinicas Vina del Mar ( Site 1042)

location_facility: Instituto Medico Alexander Fleming ( Site 1010)

location_facility: Sun Yat Sen Memorial Hospital ( Site 1323)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

location_facility: Port Macquarie Base Hospital ( Site 0153)

location_facility: CHU de Brest -Site Hopital Morvan ( Site 0441)

location_facility: Clinical Research Center of specialized types medical care-Oncology ( Site 0570)

location_facility: Inova Schar Cancer Institute ( Site 0006)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068)

location_facility: Leningrad Regional Oncology Center ( Site 0588)

location_facility: Oregon Health Sciences University ( Site 0031)

location_facility: Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0330)

location_facility: Sunnybrook Research Institute ( Site 0108)

location_facility: Cancer & Hematology Centers of Western Michigan ( Site 0013)

location_facility: Antoni van Leeuwenhoek Ziekenhuis ( Site 0480)

location_facility: Hospital de Caridade de Ijui ( Site 1038)

location_facility: Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457)

location_facility: Presidio Ospedaliero Santa Chiara ( Site 0451)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0572)

location_facility: Institut Mutualiste Montsouris ( Site 0446)

location_facility: National Taiwan University Hospital ( Site 0131)

location_facility: University of Miyazaki Hospital ( Site 0721)

location_facility: Methodist Hospital- Merriillville ( Site 0008)

location_facility: China Medical University Hospital ( Site 0132)

location_facility: Saitama Medical University International Medical Center ( Site 0708)

location_facility: Medizinische Universitaet Wien ( Site 0375)

location_facility: Fudan University Shanghai Cancer Center ( Site 1300)

location_facility: Yokohama City University Medical Center ( Site 0706)

location_facility: Centro Investigación del Cáncer James Lind ( Site 1041)

location_facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

location_facility: Nagasaki University Hospital ( Site 0719)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0114)

location_facility: Zhejiang Provincial People's Hospital ( Site 1310)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0546)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 1064)

location_facility: Fundacion Arturo Lopez Perez ( Site 1049)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0540)

location_facility: Georgia Cancer Center at Augusta University ( Site 0026)

location_facility: Harbin Medical University Cancer Hospital ( Site 1326)

location_facility: Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011)

location_facility: Institut De Cancerologie De L Ouest ( Site 0448)

location_facility: Tallaght University Hospital ( Site 0730)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

location_facility: SPb SBHI City Clinical Oncological Dispensary ( Site 0571)

location_facility: Mount Sinai Hospital Medical Center ( Site 0042)

location_facility: A.O. Universitaria di Modena ( Site 0454)

location_facility: Central Clinical Hospital with Polyclinic ( Site 0562)

location_facility: National Cheng Kung University Hospital ( Site 0134)

location_facility: Hospital Universitario Ramon y Cajal ( Site 0328)

location_facility: Radboud University Medical Center ( Site 0470)

location_facility: SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103)

location_facility: Washington University School of Medicine ( Site 0057)

location_facility: Hospital Britanico de Buenos Aires ( Site 1006)

location_facility: Bradford Hill Centro de Investigaciones Clinicas ( Site 1044)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0568)

location_facility: Hospital de Base de Sao Jose de Rio Preto ( Site 1022)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1061)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 0530)

location_facility: Instituto de Investigaciones Clinicas ( Site 1000)

location_facility: CHU Amiens Picardie Site Sud Amiens ( Site 0438)

location_facility: Universitaetsklinikum Goettingen ( Site 0345)

location_facility: Princess Margaret Cancer Centre ( Site 0107)

location_facility: Kanazawa University Hospital ( Site 0701)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0092)

location_facility: Seoul National University Hospital ( Site 0171)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 1319)

location_facility: Carolina Urologic Research Center ( Site 0070)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062)

location_facility: Universitaetsklinikum des Saarlandes ( Site 0348)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 0458)

location_facility: Associated Medical Professionals of NY ( Site 0060)

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 0575)

location_facility: Hospital Clinico San Carlos ( Site 0324)

location_facility: Oncologos del Occidente S.A. ( Site 1072)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0302)

location_facility: Dokkyo Medical University Saitama Medical Center ( Site 0707)

location_facility: Azienda Ospedaliera Santa Maria Terni ( Site 0456)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567)

location_facility: St. Joseph Heritage Healthcare ( Site 0069)

location_facility: Nanjing Drum Tower Hospital ( Site 1312)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 0065)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021)

location_facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 1330)

location_facility: W. G. Bill Hefner VA Medical Center ( Site 0029)

location_facility: University of Southern California Norris Comprehensive Cancer Center ( Site 0061)

location_facility: Centro de Diagnostico Urologico ( Site 1008)

location_facility: Nippon Medical School Hospital ( Site 0709)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585)

location_facility: University of California San Francisco ( Site 0023)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0301)

location_facility: University of North Midlands NHS Foundation Trust ( Site 0527)

location_facility: University Hospitals Cleveland Medical Center ( Site 0036)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0452)

location_facility: Hospital Consorci Sanitari Parc Tauli ( Site 0335)

location_facility: Universitaetsklinikum in Mannheim ( Site 0314)

location_facility: Russian Scientific Center of Radiology ( Site 0559)

location_facility: Peking University First Hospital ( Site 1303)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)

location_facility: Seoul National University Bundang Hospital ( Site 0175)

location_facility: USC Norris Oncology Hematology Newport Beach ( Site 0093)

title: A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Colombia
United States
China
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel