summary:
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.

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

Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide 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: Graff JN, Liang LW, Kim J, Stenzl A. KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Aug;17(23):3017-3026. doi: 10.2217/fon-2020-1008. Epub 2021 May 28.

location_facility: University of Colorado Cancer Center ( Site 0022)

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

location_facility: Centro Di Riferimento Oncologico ( Site 0800)

location_facility: Ankara University Hospital Cebeci ( Site 0613)

location_facility: Centre D Oncologie de Gentilly ( Site 0432)

location_facility: Centre Hospitalier Regional du Orleans ( Site 0430)

location_facility: Fundacion de Investigacion de Diego ( Site 1121)

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

location_facility: Yamaguchi University Hospital ( Site 0717)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 1203)

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

location_facility: Centro Oncologico Riojano Integral ( Site 1005)

location_facility: Instituto de Oncologia de Rosario ( Site 1015)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0624)

location_facility: Taipei Veterans General Hospital ( Site 0135)

location_facility: Tri-State Urologic Services PSC, Inc. ( Site 0094)

location_facility: Universitaetsklinikum Muenster ( Site 0320)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0322)

location_facility: Toho University Sakura Medical Center ( Site 0703)

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

location_facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1036)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0543)

location_facility: Noordwest Ziekenhuisgroep NWZ ( Site 0468)

location_facility: MHAT Serdika-Second Department of Medical Oncology ( Site 0505)

location_facility: Instituto Medico Alexander Fleming ( Site 1010)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0455)

location_facility: LISOD - Israeli Oncological Hospital ""MedX-ray Internationa-Department of Clinical and Scientific (

location_facility: Port Macquarie Base Hospital ( Site 0153)

location_facility: Puerto Rico Medical Research Center LLC ( Site 1122)

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

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

location_facility: Inova Schar Cancer Institute ( Site 0006)

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

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

location_facility: Municipal non-profit enterprise Kyiv City Clinical Oncology -Oncourology department ( Site 1204)

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: Baskent University Dr. Turgut Noyan Research and Training Center-ONCCOLOGY ( Site 0618)

location_facility: CISSS de la Monteregie-Centre ( Site 0119)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0636)

location_facility: MD Anderson Cancer Center Madrid ( Site 0332)

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

location_facility: Vrije Universiteit Medisch Centrum ( Site 0479)

location_facility: CNPE Regional Center of Oncology-oncourology department ( Site 1202)

location_facility: Petz Aladár Megyei Oktató Kórház-Onkológiai Osztály ( Site 1324)

location_facility: University of Massachusetts Worcester ( Site 0053)

location_facility: Maastricht University Medical Centre ( Site 0467)

location_facility: Communal Non-Commercial Enterprise ""Prykarpatski Clinical Oncological Center"" of Ivano-Frankivsk R

location_facility: Nemocnice AGEL Novy Jicin a.s. ( Site 1304)

location_facility: T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (

location_facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 0310)

location_facility: Provita Prolife Centrum Medyczne ( Site 0630)

location_facility: Froedtert Hospital & the Medical College of Wisconsin ( Site 0045)

location_facility: Institut Mutualiste Montsouris ( Site 0446)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0038)

location_facility: Assuta Ashdod Medical Center ( Site 0550)

location_facility: National Taiwan University Hospital ( Site 0131)

location_facility: University of Miyazaki Hospital ( Site 0721)

location_facility: China Medical University Hospital ( Site 0132)

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

location_facility: Yitzhak Shamir Medical Center ( Site 0547)

location_facility: Universitaetsklinikum Schleswig Holstein. ( Site 0346)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 0559)

location_facility: Ivano-Frankivsk Regional Hospital-Urology department ( Site 1208)

location_facility: Canterbury Regional Cancer & Blood Service ( Site 0195)

location_facility: Yokohama City University Medical Center ( Site 0706)

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

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 1038)

location_facility: Franciscus Gasthuis en Vlietland ( Site 0489)

location_facility: Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304)

location_facility: Az. Osp. Univ. Sta Maria della Misericordia di Udine ( Site 0460)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)

location_facility: Nagasaki University Hospital ( Site 0719)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0034)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0546)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0327)

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

location_facility: Fondazione Policlinico Universitario Agostino Gemelli ( Site 0801)

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

location_facility: Presidio Ospedaliero S. Maria Delle Grazie-U.O.C. ONCOLOGIA ( Site 0802)

location_facility: Fundacion Arturo Lopez Perez ( Site 1049)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0540)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0465)

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: University College London Hospitals NHS Foundation Trust ( Site 0482)

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

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1321)

location_facility: Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0507)

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

location_facility: Tallaght University Hospital ( Site 0730)

location_facility: Amphia Hospital Location Molengracht ( Site 0474)

location_facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0373)

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: Hacettepe Universitesi-oncology hospital ( Site 0615)

location_facility: Gabrail Cancer Center-Research ( Site 0096)

location_facility: Radboud University Medical Center ( Site 0470)

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

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0462)

location_facility: Ankara City Hospital-Medical Oncology ( Site 0616)

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: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 0464)

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

location_facility: Instituto de Investigaciones Clinicas ( Site 1000)

location_facility: Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 1325)

location_facility: Instituto Valenciano de Oncologia ( Site 0331)

location_facility: Gallipoli Medical Research Foundation ( Site 0149)

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: Hakodate Goryoukaku Hospital ( Site 0739)

location_facility: Seoul National University Hospital ( Site 0171)

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: Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 1205)

location_facility: Centro Oncologico de Integracion Regional. COIR ( Site 1007)

location_facility: Hiroshima Prefectural Hospital ( Site 0748)

location_facility: Azienda Ospedaliera Cannizzaro ( Site 0458)

location_facility: Associated Medical Professionals of NY ( Site 0060)

location_facility: Hospital Clinico San Carlos ( Site 0324)

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

location_facility: Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 1303)

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

location_facility: Ege University Medicine of Faculty ( Site 0661)

location_facility: Monash Health-Monash Medical Centre ( Site 0147)

location_facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1032)

location_facility: Royal Marsden Hospital (Sutton) ( Site 0526)

location_facility: Centre Hospitalier de Valenciennes ( Site 0439)

location_facility: Dnepropetrovsk Regional Clinical Oncology Hospital-Clinical oncological dispensary ( Site 1201)

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 1326)

location_facility: Haaglanden MC - locatie Antoniushove ( Site 0471)

location_facility: Gold Coast University Hospital ( Site 0150)

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

location_facility: Medical Oncology Ospedale San Donato ( Site 0461)

location_facility: Taichung Veterans General Hospital ( Site 0133)

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

location_facility: Kitasato University Hospital ( Site 0705)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0418)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0619)

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1040)

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: Hospital Provincial San Pedro Alcantara ( Site 0326)

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

location_facility: Pontificia Universidad Catolica de Chile ( Site 1047)

location_facility: Medizinische Universität Wien ( Site 0375)

title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
United States
Ukraine
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

acronym: Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCC

lead_sponsor: Merck Sharp & Dohme LLC

summary: This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

location_facility: University of Iowa Hospital and Clinics ( Site 1514)

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)

location_facility: Spitalul Universitar CF Cluj-Napoca ( Site 1103)

location_facility: Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site

location_facility: University of California Davis Comprehensive Cancer Center ( Site 1560)

location_facility: Hifu Terramed Conformal SRL ( Site 1111)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0354)

location_facility: Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)

location_facility: Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)

location_facility: Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)

location_facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (

location_facility: Centro Oncológico de Rosario ( Site 0003)

location_facility: Universal Clinic Oberig-Oncology Center ( Site 1461)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0204)

location_facility: Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)

location_facility: Centro de Investigación Clínica de Alta Especialidad ( Site 0715)

location_facility: Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)

location_facility: Altay Regional Oncology Dispensary ( Site 1168)

location_facility: European Interbalkan Medical Center ( Site 0455)

location_facility: MUSC Hollings Cancer Center ( Site 1533)

location_facility: Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)

location_facility: Papageorgiou General Hospital ( Site 0451)

location_facility: Vanderbilt Ingram Cancer Center ( Site 1543)

location_facility: Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)

location_facility: The University of Texas-MD Anderson Cancer Center ( Site 1536)

location_facility: Instituto Portugues de Oncologia de Lisboa ( Site 1003)

location_facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)

location_facility: Attikon University General Hospital of Athens ( Site 0454)

location_facility: C.H.U. de Nimes. Hopital Caremeau ( Site 0368)

location_facility: Istituto Europeo di Oncologia ( Site 0602)

location_facility: Onco-Hematologia de Occidente ( Site 0716)

location_facility: Hospital Universitario Carlos Haya ( Site 1255)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0703)

location_facility: Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1251)

location_facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)

location_facility: Centro Medico Privado CEMAIC ( Site 0024)

location_facility: Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)

location_facility: Haddassah Medical Organization - Ein Kerem ( Site 0553)

location_facility: Centro Oncologico Riojano Integral ( Site 0002)

location_facility: Massachusetts General Hospital ( Site 1518)

location_facility: University College Hospital London ( Site 1400)

location_facility: Fundacion Estudios Clinicos-Oncology ( Site 0026)

location_facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)

location_facility: Providence Portland Medical Center ( Site 1530)

location_facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)

location_facility: Smilow Cancer Center at Yale-New Haven ( Site 1507)

location_facility: A. C. Camargo Cancer Center ( Site 0116)

location_facility: San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 1562)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 1575)

location_facility: Winship Cancer Institute of Emory University ( Site 1512)

location_facility: West Cancer Center - East Campus ( Site 1535)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1408)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)

location_facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)

location_facility: University of Colorado Cancer Center ( Site 1506)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 1106)

location_facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0850)

location_facility: CHRU de Lille - Hopital Claude Huriez ( Site 0355)

location_facility: Hospital Universitario Marques de Valdecilla ( Site 1256)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)

location_facility: McGill University Health Centre ( Site 0162)

location_facility: Monter Cancer Center-Medical Oncology ( Site 1565)

location_facility: Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)

location_facility: A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological

location_facility: Universitaetsklinikum Tuebingen ( Site 0409)

location_facility: Hadassah Medical-Oncology department ( Site 1173)

location_facility: Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)

location_facility: Centre Hospitalier de Valence ( Site 0377)

location_facility: Hospital General Universitari Vall d Hebron ( Site 1252)

location_facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)

location_facility: Rambam Health Care Campus-Oncology Division ( Site 0552)

location_facility: Azienda Ospedaliero Universitaria Pisana ( Site 0603)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)

location_facility: Boca Raton Regional Hospital ( Site 1551)

location_facility: Szent Imre Egyetemi Oktatokorhaz ( Site 0502)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)

location_facility: Fundación Cardiovascular de Colombia ( Site 0207)

location_facility: Royal Cornwall Hospitals NHS Trust ( Site 1402)

location_facility: Gold Coast University Hospital ( Site 0054)

location_facility: Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)

location_facility: Instituto Tumori Giovanni Paolo II ( Site 0604)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0370)

location_facility: City of Hope Medical Center ( Site 1505)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 0359)

location_facility: Hospital de Especialidades Centro Medico de Occidente ( Site 0704)

location_facility: Stanford University Medical Center ( Site 1503)

location_facility: Oncologos del Occidente S.A. ( Site 0206)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 1653)

location_facility: University of Kentucky School of Medicine & Hospitals ( Site 1542)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0361)

location_facility: Soroka University Medical Center ( Site 0555)

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)

location_facility: Centro de atencion e investigacion clinica en oncologia ( Site 0706)

location_facility: New Zealand Clinical Research (Auckland) ( Site 0800)

location_facility: Hospital Sao Vicente de Paulo ( Site 0105)

location_facility: CH Lyon Sud Hospices Civils de Lyon ( Site 0350)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 1407)

location_facility: Hospital Particular do Algarve ( Site 1005)

location_facility: The Ottawa Hospital Cancer Centre ( Site 0154)

location_facility: Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)

location_facility: Consultorios de Medicina Especializada del Sector Privado ( Site 0701)

location_facility: Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)

location_facility: Medizinische Hochschule Hannover ( Site 0405)

location_facility: The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)

location_facility: Hospital Clinic i Provincial Barcelona ( Site 1253)

location_facility: Universitaetsklinikum Essen ( Site 0403)

location_facility: Inova Schar Cancer Institute ( Site 1538)

status: Recruiting

title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Chile
Canada
France
Colombia
Portugal
Hungary
United States
Ukraine
Romania
Italy
Norway
United Kingdom
Mexico
Spain
Greece
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Astellas Pharma Global Development, Inc.

summary:
The purpose of this study is to confirm the recommended phase 2 dose (RP2D) of zolbetuximab in combination with Nab-P + GEM, determine overall survival and assess the safety and tolerability of the combination treatment.

This study will also evaluate tumor markers and pharmacokinetics (PK) of zolbetuximab, Nab-P and GEM, and health-related quality of life (HRQoL).

location_facility: Novant Health Presbyterian Medical Center

location_facility: Cancer Treatment Centers of America at Eastern Regional Medical Center

location_facility: Cancer Treatment Centers of America, Chicago

location_facility: MultiCare Regional Cancer Center - Gig Harbor

title: A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination With Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects With Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

type: Registry Identifier

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:
Ireland
Italy
Australia
Brazil
Japan
Mexico
United States
China
Korea, Republic of
Spain
Turkey
Taiwan
France


title: First Real-world Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy

summary:
This is a non-interventional/observational cohort of NSCLC unresectable stage III patients treated with durvalumab.

The study will be carried out as a retrospective review of established medical records for a subset of unresectable stage III patients treated with durvalumab.

status: Active, not recruiting

study_type: Observational

time_perspective: Other

enrollment_type: Actual

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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Germany
France
Italy
Norway
United Kingdom
Australia
Netherlands
Switzerland
Belgium
Israel


title: A Non-Interventional, Multicenter, Multiple Cohort Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice

acronym: IMreal

summary: This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Argentina
Kuwait
Brazil
Croatia
Chile
Pakistan
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Hungary
India
Romania
Lebanon
Belgium
Oman
Estonia
Egypt
Philippines
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
United Arab Emirates
Spain
Bulgaria
Russian Federation

location_facility: Clinique Mutualiste L Estuaire; Oncologie

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

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

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: University Hospital Palmed; Medical Oncology Ward

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

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

location_facility: Centro Clinico Champalimaud; Unidade de Pulmao

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Centrum Onkologii w Gliwicach; II Klinika Radioterapii i Chemioterapii

location_facility: Hospital Universitario Austral; Hepatología

location_facility: Centre Hospitalier Du Mans; Maladies Respiratoires

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Hospital General de Segovia; Servicio de Oncologia

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: Ospedale Oncologico A.Businco; Div. Oncologia Medica II

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Airedale General Hospital; Research Office Ward 12

location_facility: Univerzitetni klini?ni center Maribor; Oddelek za onkologijo

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale; U.O.C. Oncologia Medica Toraco Polmonare

location_facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

location_facility: Casa di Cura La Maddalena; Oncologia Medica

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital Clinico de Granada; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital General de Mataro; Servicio de Oncologia

location_facility: Ospedale Mater Salutis; Dept of Oncology

location_facility: INSTITUTE OF ONCOLOGY LJUBLJANA; Lung Cancer Unit

location_facility: Saint George Hospital; Haematology-Oncology

location_facility: Hospital Clinico Universitario de Valladolid; Servicio de Oncologia

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Complex Oncology Center Burgas; Department of medical oncology

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Great Western Hospitals NHS Foundation Trust.

location_facility: A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Az. Osp. Uni. Ria Policlinico G. Martino; Dept. Di Med. Interna E Terapia Medica - Ii Clinica Medica

location_facility: Hospital Pedro Hispano; Servico de Oncologia

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

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

location_facility: St James Hospital; Dept of Oncology/Hematology

location_facility: Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology

location_facility: Centrum Pulmonologii i Torakochirurgii; Oddzial Pulmonologiczny z Pododdzialem Chemioterapii

location_facility: Chinese General Hospital and Medical Center

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: National Cancer Institute; Department of Thoracic Surgery and Oncology

location_facility: ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic

location_facility: Centro Hospitalar do Porto ? Hospital de Santo António; Oncologia

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

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Hospital Infanta Sofia; Servico de Oncologia

location_facility: Heartlands Hospital; Department Of Medicine

location_facility: University of Pecs; 1St Department of Medicine

location_facility: Klinikum Klagenfurt; Abteilung für Pulmologie

location_facility: Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Oddzia? Onkologii Klinicznej Odcinka A

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Oncologia

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Complex Oncological Center - Plovdiv, EOOD; Third Internal Department

location_facility: Hopital Louis Pasteur; Oncologie Hematologie

location_facility: Middle East Institute of Health Hospital

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Divisione Medicina Epatologia Padiglione Crespi

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Clinical Hospital Center Sestre Milosrdnice; Clinic for tumors

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Hopital De La Maison Blanche;Maladies Respiratoires

location_facility: Azienda Ospedaliero Universitaria Careggi; Medicina interna ed epatologia

location_facility: Ch Bretagne Atlantique; Pneumologie-Oncologie

location_facility: Sultan Qaboos Comprehensive Cancer Care & Research Center

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Ospedale Maggiore Policlinico; U.O.C. di Oncologia Medica

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Azienda Ospedaliero Universitaria Di Sassari;Oncologia

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Mumbai Oncocare Center; Medical Oncology

location_facility: CHG Henri Dufaut médecine interne-onco-hematologie

location_facility: Semmelweis Egyetem, AOK, Pulmonologiai Klinika

location_facility: Hospital Italiano de Buenos Aires; Hepatología

location_facility: Szpital Kliniczny im. Heliodora ?wi?cickiego UM w Poznaniu; Oddzia? Chemioterapii

location_facility: Tokuda Hospital; Medical Oncology Department

location_facility: Ospedale Di Circolo E Fondazione Macchi; Oncologia Medica

location_facility: Mahamana Pandit Madan Mohan Malaviya Cancer Centre-TMC

location_facility: Umhat Dr Georgi Stranski; Clinic of Chemotherapy

location_facility: Ospedale Civile SS. Antonio E Biagio DI Alessandria; Oncologia

location_facility: Grande Ospedale Metropolitano; Oncologia Medica

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

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

location_facility: Beskidzkie Centrum Onkologii - Szpital Miejski im. Jana Pawla II; Klinika Onkologii

location_facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego; Klinika Onkologii

location_facility: Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: Centrum Onkologii im. Prof. Franciszka ?ukaszczyka; Oddzia? Onkologii Klinicznej Odcinka B

location_facility: Tver Regional Oncology Clinical Dispensary

location_facility: Az. Osp. Monaldi; 1 Pneumologia Oncologica

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Complex Oncological Center - Plovdiv, EOOD; Second Internal Department

location_facility: MVR Cancer Centre and Research Institute

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Wojewodzki Szpital Zespolony; Oddzia? Onkologii

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Royal United Hospital; Oncology Department

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: Centre Hospitalier de Valence; Pneumologie

location_facility: National Cancer Centre; Medical Oncology

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: University Medical Center Ljubljana; Clinical Dept. of Gastroenterology

location_facility: Service de pneumologie Clinique médico-chirurgicale Tessier

location_facility: Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor

location_facility: Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)

location_facility: Onze Lieve Vrouwe Gasthuis, locatie Oost

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Ist. Ricovero e Cura a Carattere Scientifico-Centro Rif. Oncologico della Basilica

location_facility: International Medical Center; Oncology Department

location_facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

location_facility: Complex Oncological Center-Ruse EOOD; Department of Medical Oncology

location_facility: Aga Khan University; Department of Oncology

location_facility: Asst Santi Paolo E Carlo; Unita Operativa Di Oncologia Medica

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w ?odzi

location_facility: Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej

location_facility: Complejo Hospitalario de Orense; Servicio de Oncologia

location_facility: Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

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

location_facility: Huddersfield Royal Infirmary; The Learning Centre

location_facility: Specialized Hospital for Active Cancer Treatment, Dr. Mark Antonov Markov - Varna Ltd

location_facility: Hopital Simone Veil Eaubonne; Hopital De Jour

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

location_facility: Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Maidstone Hospital; Kent Oncology Centre

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum


title: A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

acronym: AXIOMATIC-SSP

summary: The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Janssen, LP

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Belgium
China
Italy
Norway
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel

location_facility: University of Illinois Hospital & Health Sciences System

location_facility: Kaiser Permanente Los Angeles Medical Center

status_simplified: Completed


lead_sponsor: Abivax S.A.

summary: Phase IIb study to evaluate the efficacy and the safety of 3 dose-levels of ABX464, administered daily in patients with moderate to severe Ulcerative Colitis.

location_facility: Clinical Center " Dr Dragisa Misovic Dedinje"

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Nottingham University Hospitals Queen's Medical Centre

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital

location_facility: CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

location_facility: Allen Whey Khye Lim Professional Corporation

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: CI City Clinical Hospital #6 Dept of Gastroenterology

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont

location_facility: Atlanta Center for Gastroenterology, P.C

location_facility: Szpital Uniwersytecki nr 2 im.dr J. Biziela

location_facility: M.I. Pyrogov VRCH Dept of Gastroenterology M.I. Pyrogov VNMU

location_facility: Vitebsk regoinal clinical specialized center

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: Lviv Regional Clinical Hospital D.Halytskyi Lviv NMU

location_facility: Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU

location_facility: Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: CNE Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-α] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

location_country:
Germany
Belarus
Italy
Poland
Slovenia
Slovakia
Hungary
United Kingdom
Austria
Belgium
United States
Spain
Czechia
Canada
Ukraine
Serbia
France

ipd_sharing: Undecided


title: A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

acronym: IMAGINE

summary: This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.

ReferenceType: derived

ReferenceCitation: Jordan SC, Ammerman N, Choi J, Huang E, Najjar R, Peng A, Sethi S, Sandhu R, Atienza J, Toyoda M, Ge S, Lim K, Gillespie M, Zhang X, Haas M, Vo A. Evaluation of Clazakizumab (Anti-Interleukin-6) in Patients With Treatment-Resistant Chronic Active Antibody-Mediated Rejection of Kidney Allografts. Kidney Int Rep. 2022 Feb 9;7(4):720-731. doi: 10.1016/j.ekir.2022.01.1074. eCollection 2022 Apr.

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 pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

lead_sponsor: CSL Behring

sponsor_collaborators:
CSL Behring
ICON Clinical Research

location_country:
Germany
New Zealand
Hungary
Australia
Sweden
Netherlands
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France

location_facility: Universitätsklinik für Innere Medizin III Innsbruck

location_facility: University of Louisville Research Foundation

location_facility: The Ohio State University, Comprehensive Transplant Center

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

location_facility: Vancouver General Hospital - Gordon & Leslie Diamond Centre

location_facility: Centro Hospital Universitario Dr. Preset

location_facility: Néphrologie - Pavillon Sainte Venise - CHU de Rouen - Hôpital de Bois Guillaume

location_facility: Tulane University Health Sciences Center

location_facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

location_facility: Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2

location_facility: Centre Hospitalier Universitaire Sart Tilman

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: New York Presbyterian Hospital / Weill Cornell Medical Center

location_facility: Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin

location_facility: University of California Davis Medical Center

location_facility: Methodist Healthcare System of San Antonio

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

location_facility: Medical College of WI Froedtert Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

location_facility: Medizinische Universität Wien, Allgemeines Krankenhaus der S

location_facility: Central Pennsylvania Transplant Foundation

location_facility: Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

location_facility: Indiana University (IU) Health Physicians - Kidney Diseases Clinic - Medical Diagnostic Center Location

location_facility: Pusan National University Yangsan Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

location_facility: Centrum kardiovaskulární a transplantacní chirurgie Brno

location_facility: University of Wisconsin School of Medicine and Public Health (UWSMPH)

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: University of California, San Francisco Medical Center

location_facility: University Of Colorado Hospital - Anschutz Medical Campus

location_facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

location_facility: St. Paul's Hospital, Providence Health Care, Univ. Of British Columbia

location_facility: Shared Health Inc. operating as the Health Sciences Centre

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital)

location_facility: Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor

location_facility: Debreceni Egyetem, Klinikai Központ, Auguszta

location_facility: Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics

location_facility: The University of Queensland - Princess Alexandra Hospital (PAH)

location_facility: Uppsala Universitet - Akademiska Sjukhuset

location_facility: Washington University School of Medicine - Infectious Diseases (WU ID) Clinic

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: CHU GRENOBLE ALPES - Consultation Néphrologie Bureau des ARC (Côté Chartreuse, Rez-de-Chaussée Haut)


title: A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

summary:
This study will compare DS-8201a to physician choice standard treatment.

Participants must have HER2-low breast cancer that has been treated before.

Participants' cancer:

Cannot be removed by an operation
Has spread to other parts of the body

ReferenceType: result

ReferenceCitation: Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/NEJMoa2203690. Epub 2022 Jun 5.

oa_colors: green other

evidence: open (via free article)

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

license: public-domain

license_normalized: public-domain

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

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

lead_sponsor: Daiichi Sankyo, Inc.

collaborators:
Daiichi Sankyo Co., Ltd.
AstraZeneca

sponsor_collaborators:
Daiichi Sankyo, Inc.
Daiichi Sankyo Co., Ltd.
AstraZeneca

location_country:
Germany
Japan
Canada
France
Portugal
Hungary
Switzerland
United States
Belgium
China
Italy
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Centre Hospitalier Wallonie picarde - Site IMC

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

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

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

location_facility: SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: AKH - Medizinische Universität Wien (4305)

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: University of California at San Francisco (PARENT)

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

location_facility: Klinikum der Universitaet Muenchen - Campus Grosshardern

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Memorial Healthcare System MRH Cancer Center

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

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

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

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Hospital General Universitario de Valencia

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

location_facility: Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA

location_facility: Sun Yat-sen Memorial hospital, Sun Yat-sen University

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Cancer Treatment Centers of America-Georgia

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

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

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Karolinska universitetssjukhuset - Solna

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

location_facility: Seoul National University Bundang Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario

location_facility: The Methodist Hospital Research Institute

location_facility: Florida Cancer Specialists (South Region)

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

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: Sylvester Comprehensive Cancer Center - Deerfield Beach

location_facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico

location_facility: University General Hospital of Heraklion

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Brig Center for Cancer Care and Survivorship

location_facility: SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement

location_facility: McGill University - Dept. Oncology Clinical Research Program

location_facility: Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)

location_facility: Ironwood Cancer & Research Centers - Chandler II

location_facility: Cancer Care Associates Medical Group, Inc. TORI

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Nottingham University Hospitals City Campus

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: General Hospital of Ningxia Medical University

location_facility: Kyungpook National University Chilgok Hospital


acronym: NATALEE

lead_sponsor: Novartis Pharmaceuticals

summary: A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)

sponsor_collaborators:
Novartis Pharmaceuticals
Translational Research in Oncology

location_facility: Comprehensive Cancer Centers of Nevada .

location_facility: Center for Cancer and Blood Disorders Research Department

location_facility: Fred Hutchinson Cancer Center Medical Oncology

location_facility: Valley Breast Care and Women s Health Center

location_facility: Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01

location_facility: MD Anderson Cancer Center/University of Texas .

location_facility: UCLA Santa Monica Hematology / Oncology Regulatory-2

location_facility: University of Alabama at Birmingham/ Kirklin Clinic .

location_facility: Winship Cancer Institute of Emory University .

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center .

location_facility: Eastern Connecticut Hematology and Oncology Associates Regulatory

location_facility: University of California San Francisco .

location_facility: Florida Cancer Specialists- East Region .

location_facility: Metro Minnesota CCOP Metro Minneapolis CCOP

location_facility: St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr

location_facility: Cancer Treatment Centers of America Eastern Regional Medical Center

location_facility: Central Coast Medical Oncology Corporation Onc Dept

location_facility: Orlando Health Clinical Trials Orlando Health Inc

location_facility: Baylor Charles A. Sammons Cancer Center .

location_facility: Southern California Oncology Research Alliance SCORA .

location_facility: UCLA Pasadena Health Care Hematology Oncology .

location_facility: UCLA Porter Ranch Hematology and Oncology .

title: A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

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

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

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Canada
France
Hungary
United States
Romania
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alpha for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Due to Myelodysplastic Syndrome (MDS) ESA in Native Subjects Who Require Red Blood Cell Transfusions

acronym: COMMANDS

summary: The purpose of this study is to determine the effectiveness of luspatercept (ACE-536) compared to epoetin alfa on red blood cell (RBC) transfusion independence (for at least 12 weeks) with a concurrent hemoglobin increase of at least 1.5 g/dL in participants with anemia due to revised international prognostic scoring system (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) who require RBC transfusions and have never been exposed to erythropoiesis stimulating agent (ESA).

lead_sponsor: Celgene

collaborators: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

location_country:
Germany
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Lithuania
Portugal
Hungary
Switzerland
United States
Ukraine
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Utah Cancer Specialists - South Salt Lake


title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

summary: The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

ReferenceCitation: Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

publisher_dissemination: Future Science Ltd

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Finland
Germany
New Zealand
Argentina
Australia
Brazil
Japan
Chile
Canada
France
Colombia
Portugal
United States
Romania
Belgium
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Instituto Medico Especializado Alexander Fleming


title: A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302)

summary: The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.

ReferenceCitation: Bekaii-Saab TS, Valle JW, Van Cutsem E, Rimassa L, Furuse J, Ioka T, Melisi D, Macarulla T, Bridgewater J, Wasan H, Borad MJ, Abou-Alfa GK, Jiang P, Lihou CF, Zhen H, Asatiani E, Feliz L, Vogel A. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020 Oct;16(30):2385-2399. doi: 10.2217/fon-2020-0429. Epub 2020 Jul 17.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

unpaywall_oa_status: hybrid

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Finland
Germany
Ireland
Japan
Canada
France
Denmark
Switzerland
United States
Belgium
China
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Israel

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: West Virginia University Cancer Institute

location_facility: Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari

location_facility: Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

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

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Istituto Nazionale Tumori Regina Elena Irccs

location_facility: University Hospitals Cleveland Medical Center

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

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Karolinska Institute Universitetssjukhuset Solna

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Mount Sinai Medical Center Comprehensive Cancer Center

location_facility: Ochsner Clinic Foundation Ocf Ochsner Cancer Institute Oci

location_facility: Universita Degli Studi Della Campania Luigi Vanvitelli U.O.C. Oncologia Medica

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

location_facility: Klinikum Der Johann Wolfgang Goethe University

location_facility: Kent Oncology Centre - Maidstone Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Comprehensive Cancer Centers of Nevada-Twain

location_facility: Winship Cancer Institute of Emory University

location_facility: Hospital General Universitario de Valencia

location_facility: Nova Scotia Health Authority/Qeii Health Sciences Centre

location_facility: Imperial College Healthcare Nhs Trust - Hammersmith Hospital

location_facility: Tongji Hospital Huazhong University of Science and Technology

location_facility: Hospital Regional Universitario de Malaga

location_facility: Azienda Ospedaliero Universitaria Delle Marche

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: University College London Hospitals (Uclh)

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Greenville Hospital System University Medical Center Institute For Translational Oncology Research

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Tianjin Medical University Cancer Institute Hospital

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: McGill University Health Centre Research Institute

location_facility: Ordensklinikum Krankenhaus Der Barmherzigen Schwestern Linz

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Georgetown University-Lombardi Comprehensive Cancer Center

location_facility: Hopital Europeen Georges Pompidou (Hegp)

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Centro Ricerche Cliniche Di Verona (Crc)

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

location_facility: University Hospital Coventry and Warwickshire

location_facility: Baylor Scott and White Research Institute


title: A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

acronym: FIRST

summary: Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated both in the PD-L1 positive and overall population of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.

lead_sponsor: Tesaro, Inc.

collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_country:
Finland
Germany
Poland
Czechia
Canada
France
Belarus
Denmark
United States
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Netherlands
Spain
Greece
Israel


summary: This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

location_facility: Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: London Health Sciences Centre Uni Campus

location_facility: Cork University Hospital; Clinical Research Facility

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

location_facility: Fondazione Istituto S. Raffaele - Giglio; UO Neurologia

location_facility: Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

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

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

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

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Sykehuset Buskerud HF; Nevrologisk avdeling

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Hospital General de Castellon; Servicio de Neurología

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Montreal Neurological Institute and Hospital

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Karolinska Universitetssjukhuset Solna Neurology

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

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

location_facility: Mustafa Kemal Ataturk UTF; Department of norology

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

location_facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Hopital Roger Salengro Service de Neurologie

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov

location_facility: East Tallinn Central Hospital; Neurology Department

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: Centralsjukhuset; Neurologi och rehabiliteringskliniken

location_facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

location_facility: Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA

location_facility: Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Haukeland universitetssykehus; Nevrologisk avdeling

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

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia

location_facility: Gazi University Medical Faculty; Departmant of Norology

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

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

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Hospital Universitario Central de Asturias; Servicio de Neurología

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia

title: A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

location_country:
Finland
Ireland
Poland
Argentina
Kuwait
Brazil
Turkey
Croatia
Czechia
Canada
France
Slovenia
Portugal
Slovakia
Hungary
Denmark
Belgium
Estonia
Italy
Norway
United Kingdom
Netherlands
Mexico
Spain
Bulgaria
Sweden


summary:
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.

This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

location_facility: Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: Saint Louis University School of Medicine

location_facility: Tulane University Health Sciences Center

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: University Hospital of Girona Dr. Josep Trueta

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Digestive Health Associates of Texas (DHAT)

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego

location_facility: University of Pittsburgh Medical Center - Center for Liver Diseases

location_facility: University of California Davis Medical Center

location_facility: University of Sydney - Royal Prince Alfred Hospital

location_facility: Baylor College of Medicine - Baylor Heart Clinic

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou

location_facility: University of Colorado, School of Medicine - Hepatology Clinic - Anschutz

location_facility: WestGlen Gastrointestinal Consultants, P.A.

location_facility: Ohio State University Wexner Medical Center

location_facility: University of Vermont Medical Center Gastro

location_facility: Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Beaujon

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: University of Washington Harborview Medical Center

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

location_facility: The Institute for Digestive Health & Liver Disease at Mercy Medical Center

location_facility: University of Calgary, Cumming School of Medicine

location_facility: University of Miami Schiff Center for Liver Diseases

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Cochin

location_facility: Toronto Center for Liver Disease - Francis Family Liver Clinic

location_facility: University of Birmingham Institute of Biomedical Research

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Synexus Hexham Clinical Research Centre, Hexham (DRS)

location_facility: University of Mississippi Medical Center

location_facility: North Tees (DRS) Synexus North Teesside Clinical Research Centre

location_facility: Virginia Commonwealth University School of Medicine

status: Terminated

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_country:
Germany
Poland
United Kingdom
Australia
Japan
United States
Korea, Republic of
Spain
Canada
France

status_simplified: Unknown


acronym: TROPHY U-01

lead_sponsor: Gilead Sciences

summary: The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

ReferenceCitation: Tagawa ST, Balar AV, Petrylak DP, Kalebasty AR, Loriot Y, Flechon A, Jain RK, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos CE, Pouessel D, Sternberg CN, Hong Q, Goswami T, Itri LM, Grivas P. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021 Aug 1;39(22):2474-2485. doi: 10.1200/JCO.20.03489. Epub 2021 Apr 30.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: Centre Hospitalier Regional Universitaire Brest

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Centrum fur Hamatologie und Onkologie Bethanien

location_facility: Eastern Connecticut Hematology and Oncology Associates

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Precision Cancer Research / New Mexico Oncology & Hematology Consultants

location_facility: Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: University of Utah - Huntsman Cancer Hospital (IP Shipping Address)

location_facility: General Hospital of Patras Agios Andreas

location_facility: Oncology Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Southern Illinois University School of Medicine, Simmons Cancer Institute

location_facility: Houston Methodist Hospital, Houston Methodist Cancer Center

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

location_facility: Henry Dunant Hospital Center, 4th Oncology Department

location_facility: Hospital Universitario Clinico San Carlos

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Drug Shipping Address: New York-Presbyterian Hospital

location_facility: Universitätsklinikum Frankfurt, Klinik für Urologie

location_facility: The University of Arizona Cancer Center-North Campus

location_facility: University General Hospital of Ioannina, Oncology Department

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Thompson Oncology Group - Knoxville West

location_facility: Yonsei University - Wonju Severance Christian Hospital

location_facility: Hospital Universitario Puera de Hierro Majadahonda

location_facility: Klinikum rechts der Isar der Technischen Universität München, Urologische Klinik und Poloklinik

location_facility: Centre Hospitalier Departmental (CHD) Vendee

location_facility: Anassa General Clinic, Oncology-Chemotherapy Department

location_facility: Universitatsklinikum Tubingen, Klinik fur Urologie

location_facility: Pusan National University Yangsan Hospital

location_facility: Institut Catala d'Oncologia Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita

location_facility: Yonsei University Health System, Severance Hospital

location_facility: Athens Medical Center, Oncology Department

location_facility: Hospitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Chonnam National University Hwasun Hospital

location_facility: University of Wisconsin Clinical Science Center

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Hastanesi

location_facility: Dicle Universitesi Tip Fakultesi Hastanesi

location_facility: Centre Hospitalier Universitaire De Nimes - Hopital Universitaire Caremeau

location_facility: Hopital European Georges-Pompidou (HEGP)

location_facility: T.C. Saglik Bakanligi Goztepe Prof Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Winship Cancer Institute, Emory University

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Izmir Medical Point Hastanesi, Medikal Onkoloji Departmant

location_facility: Baskent Universitesi Adana Dr.Turgut Noyan Uygulama ve Arastima Merkezi

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Besancon, Hopital Jean Minjoz

location_facility: Indiana University Melvin and Bren Simon Cancer Center

title: A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
United States
Korea, Republic of
Spain
Greece
Turkey
France


summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

ReferenceCitation: Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.

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

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Cortes J, Kim SB, Chung WP, Im SA, Park YH, Hegg R, Kim MH, Tseng LM, Petry V, Chung CF, Iwata H, Hamilton E, Curigliano G, Xu B, Huang CS, Kim JH, Chiu JWY, Pedrini JL, Lee C, Liu Y, Cathcart J, Bako E, Verma S, Hurvitz SA; DESTINY-Breast03 Trial Investigators. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Engl J Med. 2022 Mar 24;386(12):1143-1154. doi: 10.1056/NEJMoa2115022.

location_facility: Houston Methodist Hospital / Houston Methodist Cancer Center

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

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

location_facility: Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

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

location_facility: Vanderbilt Breast Center at One Hundred Oaks

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Institut de cancérologie de l'ouest, site René Gauducheau

location_facility: Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

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

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Azienda Ospealiera della Provincia di Lecco

location_facility: North Shore Hematology Oncology Associates, PC

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Koo Foundation, Sun Yat-Sen Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Wake Forest University Baptist Medical Center

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Nottingham University Hospitals City Campus

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

location_facility: Peninsula and South Eastern Haematology & Oncology Group

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira

title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

location_country:
Germany
Italy
United Kingdom
Hong Kong
Australia
Brazil
Japan
Belgium
United States
China
Korea, Republic of
Spain
Taiwan
Canada
France