Spots Global Cancer Trial Database for Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
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Trial Identification
Brief Title: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Official Title: A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy
Study ID: NCT06136624
Conditions
Study Description
Brief Summary: This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) and to radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) as assessed by blinded independent central review (BICR) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS and rPFS per PCWG Modified RECIST 1.1 as assessed by BICR in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Colorado Clinical Research ( Site 0067), Lakewood, Colorado, United States
University of Kentucky Chandler Medical Center ( Site 0048), Lexington, Kentucky, United States
Baltimore Veterans Affairs Medical Center ( Site 0069), Baltimore, Maryland, United States
Metro-Minnesota Community Clinical Oncology ( Site 0014), Saint Louis Park, Minnesota, United States
Comprehensive Cancer Centers of Nevada ( Site 0010), Las Vegas, Nevada, United States
Rutgers Cancer Institute of New Jersey ( Site 0033), New Brunswick, New Jersey, United States
University Hospitals Cleveland Medical Center ( Site 0043), Cleveland, Ohio, United States
University of Virginia Health System ( Site 0054), Charlottesville, Virginia, United States
Blue Ridge Cancer Care ( Site 0004), Roanoke, Virginia, United States
Dubbo Hospital ( Site 0235), Dubbo, New South Wales, Australia
Macquarie University-MQ Health Clinical Trials Unit ( Site 0234), Macquarie University, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 0232), Westmead, New South Wales, Australia
Princess Alexandra Hospital-Cancer Care Serices ( Site 0237), Brisbane, Queensland, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230), Melbourne, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276), Linz, Oberosterreich, Austria
Centre Hospitalier de l'Université de Montréal ( Site 0326), Montréal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Quebec City, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer, Sherbrooke, Quebec, Canada
IC La Serena Research ( Site 0356), La Serena, Coquimbo, Chile
Clinical Research Chile SpA ( Site 0358), Valdivia, Los Rios, Chile
Clinica Universidad Catolica del Maule-Oncology ( Site 0355), Talca, Maule, Chile
FALP ( Site 0353), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 0351), Santiago, Region M. De Santiago, Chile
Bradford Hill Norte ( Site 0357), Antofagasta, , Chile
Chongqing University Cancer Hospital ( Site 0416), Chongqing, Chongqing, China
Hubei Cancer Hospital-Urinary surgery ( Site 0406), Wuhan, Hubei, China
Fudan University Shanghai Cancer Center-Urology department ( Site 0376), Shanghai, Shanghai, China
Nanchong Central Hospital-urology ( Site 0422), Nanchong, Sichuan, China
Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419), Urumqi, Xinjiang, China
Zhejiang Provincial People's Hospital-Urology ( Site 0378), Hangzhou, Zhejiang, China
The First Hospital of Jiaxing-urology ( Site 0380), Jiaxing, Zhejiang, China
Ningbo First Hospital-Urology ( Site 0383), Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379), Wenzhou, Zhejiang, China
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553), Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554), Ostrava, Moravskoslezsky Kraj, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555), Olomouc, Olomoucky Kraj, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551), Praha, Praha 5, Czechia
Rigshospitalet ( Site 0576), Copenhagen, Hovedstaden, Denmark
Odense Universitetshospital-Department of oncology ( Site 0579), Odense, Syddanmark, Denmark
Vejle Sygehus ( Site 0578), Vejle, Syddanmark, Denmark
Tampereen yliopistollinen sairaala ( Site 0604), Tampere, Pirkanmaa, Finland
Kuopion Yliopistollinen Sairaala ( Site 0603), Kuopio, Pohjois-Savo, Finland
Turku University Hospital-Department of Oncology ( Site 0601), Turku, Varsinais-Suomi, Finland
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627), Strasbourg, Alsace, France
Centre Hospitalier de la Côte Basque ( Site 0633), Bayonne, Pyrenees-Atlantiques, France
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit, Munich, Bayern, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679), Berlin, , Germany
Queen Mary Hospital ( Site 0727), Hksar, , Hong Kong
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752), Kecskemét, Bacs-Kiskun, Hungary
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756), Budapest, Pest, Hungary
Tallaght University Hospital ( Site 0801), Dublin, , Ireland
Emek Medical Center ( Site 0830), Afula, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0826), Haifa, , Israel
Hadassah Medical Center ( Site 0833), Jerusalem, , Israel
Rabin Medical Center ( Site 0828), Petah Tikva, , Israel
Sheba Medical Center ( Site 0827), Ramat Gan, , Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 08, Meldola, Emilia-Romagna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877), Milan, Lombardia, Italy
Toho University Sakura Medical Center ( Site 0906), Sakura, Chiba, Japan
Kanazawa Medical University Hospital ( Site 0909), Uchinada, Ishikawa, Japan
Bell Land General Hospital ( Site 0913), Sakai, Osaka, Japan
National Hospital Organization Kumamoto Medical Center ( Site 0924), Kumamoto, , Japan
Asan Medical Center-Oncology ( Site 1402), Songpagu, Seoul, Korea, Republic of
Seoul National University Hospital-Oncology ( Site 1401), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1405), Seoul, , Korea, Republic of
Radboudumc-Medical Oncology ( Site 1152), Nijmegen, Gelderland, Netherlands
Meander Medisch Centrum ( Site 1157), Amersfoort, Utrecht, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151), Schiedam, Zuid-Holland, Netherlands
Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227), Lørenskog, Akershus, Norway
Sykehuset Østfold Kalnes ( Site 1228), Sarpsborg, Ostfold, Norway
St. Olavs Hospital-Kreftklinikken ( Site 1231), Trondheim, Sor-Trondelag, Norway
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302), Bydgoszcz, Kujawsko-pomorskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310), Siedlce, Mazowieckie, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303), Koszalin, Zachodniopomorskie, Poland
Ad-Vance Medical Research-Research ( Site 1353), Ponce, , Puerto Rico
Pan American Center for Oncology Trials - Ciudadela ( Site 1351), San Juan, , Puerto Rico
National Cancer Centre Singapore ( Site 1377), Singapore, Central Singapore, Singapore
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431), Madrid, Madrid, Comunidad De, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433), Madrid, Madrid, Comunidad De, Spain
Complexo Hospitalario Universitario de Ourense ( Site 1426), Ourense, Orense, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430), Valencia, Valenciana, Comunitat, Spain
Hospital Lucus Augusti-Oncology ( Site 1432), Lugo, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428), Sevilla, , Spain
Karolinska Universitetssjukhuset Solna ( Site 1478), Stockholm, Stockholms Lan, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477), Uppsala, Uppsala Lan, Sweden
Sahlgrenska Universitetssjukhuset ( Site 1479), Gothenburg, Vastra Gotalands Lan, Sweden
China Medical University Hospital-Department of Urology ( Site 1503), Taichung, , Taiwan
National Taiwan University Hospital-Urology ( Site 1506), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1505), Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504), Taoyuan, , Taiwan
Gulhane Egitim Arastirma Hastanesi ( Site 1558), Ankara, , Turkey
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551), Ankara, , Turkey
Memorial Ankara Hastanesi-Medical Oncology ( Site 1557), Ankara, , Turkey
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555), Istanbul, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553), Istanbul, , Turkey
Addenbrooke's Hospital ( Site 1605), Cambridge, Cambridgeshire, United Kingdom
The Royal Cornwall Hospital ( Site 1610), Truro, England, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1603), Glasgow, Glasgow City, United Kingdom
University College London Hospital ( Site 1612), London, London, City Of, United Kingdom
The Christie NHS Foundation Trust ( Site 1608), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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