Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
Start Date
5/20/2024
Completion Date
1/15/2029
Summary
Substudy 01A is part of a larger research study that is testing experimental treatments for metastatic castration-resistant prostate cancer (mCRPC). The larger study is the umbrella study (U01). The goal of substudy 01A is to evaluate the safety and efficacy of opevesostat-based treatment combinations, or as a single agent, in participants with mCRPC. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for the opevesostat-based treatment combinations. There will be no hypothesis testing in this study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Opevesostat
Olaparib
Docetaxel
Cabazitaxel
Fludrocortisone acetate
Dexamethasone
Prednisone
Conditions
Locations
UCSD Moores Cancer Center ( Site 0039)
La Jolla, California 92037
United States
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
Los Angeles, California 90404
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
Miami, Florida 33136
United States
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, Maryland 21201
United States
Rutgers Cancer Institute of New Jersey ( Site 0033)
New Brunswick, New Jersey 08903-2681
United States
University Hospitals Cleveland Medical Center ( Site 0043)
Cleveland, Ohio 44106
United States
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
Milwaukee, Wisconsin 53226
United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
Macquarie University, New South Wales 2109
Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
Greenslopes, Queensland 4120
Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)
Melbourne, Victoria 3000
Australia
Centre Hospitalier de l'Université de Montréal ( Site 0200)
Montreal, Quebec H2X 3E4
Canada
Jewish General Hospital ( Site 0206)
Montreal, Quebec H3T 1E2
Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
Québec, Quebec G1J 1Z4
Canada
CIDO SpA-Oncology ( Site 0302)
Temuco, Biobio 4810218
Chile
Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
Talca, Maule Region 3465584
Chile
FALP ( Site 0301)
Santiago, Region M. de Santiago 7500921
Chile
Pontificia Universidad Catolica de Chile ( Site 0303)
Santiago, Region M. de Santiago 832000
Chile
Bradfordhill ( Site 0300)
Santiago, Region M. de Santiago 8420383
Chile
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
Bogotá, Bogota D.C. 110131
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
Bogotá, Bogota D.C. 111321
Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
Valledupar, Cesar Department 200001
Colombia
IMAT S.A.S ( Site 0404)
Montería, Departamento de Córdoba 230002
Colombia
Fundación Valle del Lili-Oncology CIC ( Site 0403)
Cali, Valle del Cauca Department 760032
Colombia
Herlev and Gentofte Hospital ( Site 0501)
Copenhagen, Capital Region 2730
Denmark
Aalborg Universitetshospital, Syd ( Site 0503)
Aalborg, North Denmark 9000
Denmark
Vaasan Keskussairaala ( Site 0603)
Vaasa, Pohjanmaa 65130
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
Helsinki, Uusimaa 00029
Finland
Docrates Syöpäsairaala ( Site 0602)
Helsinki, Uusimaa 00180
Finland
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
Bordeaux, Aquitaine 33076
France
Hopitaux Universitaires de Strasbourg ( Site 0700)
Strasbourg, Bas-Rhin 67200
France
Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
Paris, 75015
France
Gustave Roussy ( Site 0701)
Villejuif, Île-de-France Region 94805
France
Universitaetsklinikum Heidelberg ( Site 0805)
Heidelberg, Baden-Wurttemberg 69120
Germany
Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
Tübingen, Baden-Wurttemberg 72076
Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
Munich, Bavaria 81675
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
Berlin, 10117
Germany
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
Hamburg, 20246
Germany
St. Vincent's University Hospital ( Site 0901)
Dublin, Dublin D04 T6F4
Ireland
Cork University Hospital ( Site 0902)
Cork, T12 DC4A
Ireland
Tallaght University Hospital ( Site 0900)
Dublin, D24 NR0A
Ireland
Rambam Health Care Campus-Oncology Division ( Site 1002)
Haifa, 3109601
Israel
Rabin Medical Center ( Site 1001)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 1000)
Ramat Gan, 5265601
Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
Rome, Lazio 00168
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
Milan, Lombardy 20133
Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
Rozzano, Milano 20089
Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)
Verona, 37134
Italy
Toho University Sakura Medical Center ( Site 1201)
Sakura, Chiba 285-8741
Japan
Yokohama City University Medical Center ( Site 1203)
Yokohama, Kanagawa 232-0024
Japan
The Jikei University Hospital ( Site 1202)
Mitato, Tokyo 105-8471
Japan
Kyushu University Hospital ( Site 1204)
Fukuoka, 812-8582
Japan
Auckland City Hospital ( Site 1333)
Auckland, 1023
New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1402)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
Warsaw, Masovian Voivodeship 02-781
Poland
Uniwersyteckie Centrum Kliniczne ( Site 1405)
Gdansk, Pomeranian Voivodeship 80-952
Poland
Asan Medical Center-Oncology ( Site 1500)
Songpagu, Seoul 05505
South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
Seoul, 03722
South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
Seoul, 06351
South Korea
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
Madrid, Madrid, Comunidad de 28034
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
Barcelona, 08035
Spain
Hospital General Universitario Gregorio Marañón ( Site 1601)
Madrid, 28007
Spain
Hospital Clinico San Carlos-Oncology Department ( Site 1604)
Madrid, 28040
Spain
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
Kaohsiung Niao Sung Dist, Kaohsiung 83301
Taiwan
China Medical University Hospital ( Site 1703)
Taichung, 404332
Taiwan
Taipei Veterans General Hospital ( Site 1701)
Taipei, 112
Taiwan
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
Taoyuan, 333
Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
Adana, 01250
Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
Ankara, 06230
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 1801)
Ankara, 06800
Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
Istanbul, 34668
Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
Istanbul, 34722
Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1902)
Cambridge, Cambridgeshire CB2 2QQ
United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1904)
Glasgow, Glasgow City G12 0YN
United Kingdom
Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
Preston, Lancashire PR2 9HT
United Kingdom
University College London Hospital ( Site 1905)
London, London, City of NW1 2PG
United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 1903)
Birmingham, B15 2TH
United Kingdom