Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-17
220
Participants Needed
77
Research Sites
243 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
O
Orion Corporation, Orion Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- Prostate cancer progression and receipt of androgen deprivation therapy or bilateral orchiectomy within 6 months before screening
- Evidence of disease progression after last anti-androgen therapy (flutamide >4 weeks, bicalutamide or nilutamide >6 weeks before screening)
- Current evidence of metastatic disease
- Prior treatment with 1 to 2 novel hormonal agents for hormone-sensitive or castration-resistant prostate cancer with disease progression
- Stable doses of bone resorptive therapy for more than 4 weeks before randomization
- Recovery to less than Grade 1 or baseline from adverse events due to previous anticancer therapies
- Well-controlled HIV infection on antiretroviral therapy
- Hepatitis B surface antigen positive with antiviral therapy for at least 4 weeks and undetectable viral load
- History of Hepatitis C infection with undetectable viral load
You will not qualify if you...
- History of pituitary dysfunction
- Poorly controlled diabetes mellitus
- Active or unstable cardiovascular or cerebrovascular disease within 6 months before treatment
- History or family history of long corrected QT interval syndrome
- Myelodysplastic syndrome or acute myeloid leukemia or suggestive features
- History or current adrenal insufficiency
- History of pneumonitis requiring steroids or current pneumonitis
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Major surgery, including local prostate intervention (except biopsy) within 28 days before randomization without recovery
- Unstable thyroid hormone therapy dose within 6 months before treatment
- Whole blood transfusion within 120 days before randomization
- Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Prior radiotherapy within 2 weeks before treatment or radiation-related toxicities requiring corticosteroids
- Live or live-attenuated vaccine within 30 days before treatment
- Diagnosis of immunodeficiency or chronic immunosuppressive therapy within 7 days before treatment
- Known additional progressing malignancy requiring active treatment in past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infection requiring systemic therapy
- Concurrent active hepatitis B or C infections
AI-Screening
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Trial Site Locations
Total: 77 locations
1
UCSD Moores Cancer Center ( Site 0039)
La Jolla, California, United States, 92037
Actively Recruiting
2
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
Los Angeles, California, United States, 90404
Actively Recruiting
3
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
Miami, Florida, United States, 33136
Actively Recruiting
4
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, Maryland, United States, 21201
Active, Not Recruiting
5
Rutgers Cancer Institute of New Jersey ( Site 0033)
New Brunswick, New Jersey, United States, 08903-2681
Actively Recruiting
6
University Hospitals Cleveland Medical Center ( Site 0043)
Cleveland, Ohio, United States, 44106
Actively Recruiting
7
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
8
Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
Macquarie University, New South Wales, Australia, 2109
Actively Recruiting
9
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
Greenslopes, Queensland, Australia, 4120
Actively Recruiting
10
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)
Melbourne, Victoria, Australia, 3000
Actively Recruiting
11
Centre Hospitalier de l'Université de Montréal ( Site 0200)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
12
Jewish General Hospital ( Site 0206)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
13
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
14
CIDO SpA-Oncology ( Site 0302)
Temuco, Biobio, Chile, 4810218
Active, Not Recruiting
15
Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
Talca, Maule Region, Chile, 3465584
Actively Recruiting
16
FALP ( Site 0301)
Santiago, Region M. de Santiago, Chile, 7500921
Active, Not Recruiting
17
Pontificia Universidad Catolica de Chile ( Site 0303)
Santiago, Region M. de Santiago, Chile, 832000
Actively Recruiting
18
Bradfordhill ( Site 0300)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
19
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
Bogotá, Bogota D.C., Colombia, 110131
Actively Recruiting
20
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
Bogotá, Bogota D.C., Colombia, 111321
Actively Recruiting
21
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
Valledupar, Cesar Department, Colombia, 200001
Actively Recruiting
22
IMAT S.A.S ( Site 0404)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
23
Fundación Valle del Lili-Oncology CIC ( Site 0403)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
24
Herlev and Gentofte Hospital ( Site 0501)
Copenhagen, Capital Region, Denmark, 2730
Actively Recruiting
25
Aalborg Universitetshospital, Syd ( Site 0503)
Aalborg, North Denmark, Denmark, 9000
Actively Recruiting
26
Vaasan Keskussairaala ( Site 0603)
Vaasa, Pohjanmaa, Finland, 65130
Actively Recruiting
27
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
Helsinki, Uusimaa, Finland, 00029
Actively Recruiting
28
Docrates Syöpäsairaala ( Site 0602)
Helsinki, Uusimaa, Finland, 00180
Actively Recruiting
29
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
Bordeaux, Aquitaine, France, 33076
Actively Recruiting
30
Hopitaux Universitaires de Strasbourg ( Site 0700)
Strasbourg, Bas-Rhin, France, 67200
Actively Recruiting
31
Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
Paris, France, 75015
Actively Recruiting
32
Gustave Roussy ( Site 0701)
Villejuif, Île-de-France Region, France, 94805
Actively Recruiting
33
Universitaetsklinikum Heidelberg ( Site 0805)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
34
Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
35
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
Munich, Bavaria, Germany, 81675
Actively Recruiting
36
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
Berlin, Germany, 10117
Active, Not Recruiting
37
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
Hamburg, Germany, 20246
Actively Recruiting
38
St. Vincent's University Hospital ( Site 0901)
Dublin, Dublin, Ireland, D04 T6F4
Actively Recruiting
39
Cork University Hospital ( Site 0902)
Cork, Ireland, T12 DC4A
Actively Recruiting
40
Tallaght University Hospital ( Site 0900)
Dublin, Ireland, D24 NR0A
Actively Recruiting
41
Rambam Health Care Campus-Oncology Division ( Site 1002)
Haifa, Israel, 3109601
Actively Recruiting
42
Rabin Medical Center ( Site 1001)
Petah Tikva, Israel, 4941492
Actively Recruiting
43
Sheba Medical Center ( Site 1000)
Ramat Gan, Israel, 5265601
Actively Recruiting
44
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
Rome, Lazio, Italy, 00168
Completed
45
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
Milan, Lombardy, Italy, 20133
Actively Recruiting
46
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
Rozzano, Milano, Italy, 20089
Actively Recruiting
47
Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)
Verona, Italy, 37134
Actively Recruiting
48
Toho University Sakura Medical Center ( Site 1201)
Sakura, Chiba, Japan, 285-8741
Actively Recruiting
49
Yokohama City University Medical Center ( Site 1203)
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
50
The Jikei University Hospital ( Site 1202)
Mitato, Tokyo, Japan, 105-8471
Completed
51
Kyushu University Hospital ( Site 1204)
Fukuoka, Japan, 812-8582
Actively Recruiting
52
Auckland City Hospital ( Site 1333)
Auckland, New Zealand, 1023
Actively Recruiting
53
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1402)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
Actively Recruiting
54
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
55
Uniwersyteckie Centrum Kliniczne ( Site 1405)
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
56
Asan Medical Center-Oncology ( Site 1500)
Songpagu, Seoul, South Korea, 05505
Actively Recruiting
57
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
Seoul, South Korea, 03722
Actively Recruiting
58
Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
Seoul, South Korea, 06351
Actively Recruiting
59
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
60
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
61
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
Barcelona, Spain, 08035
Actively Recruiting
62
Hospital General Universitario Gregorio Marañón ( Site 1601)
Madrid, Spain, 28007
Actively Recruiting
63
Hospital Clinico San Carlos-Oncology Department ( Site 1604)
Madrid, Spain, 28040
Actively Recruiting
64
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
Actively Recruiting
65
China Medical University Hospital ( Site 1703)
Taichung, Taiwan, 404332
Actively Recruiting
66
Taipei Veterans General Hospital ( Site 1701)
Taipei, Taiwan, 112
Actively Recruiting
67
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
Taoyuan, Taiwan, 333
Actively Recruiting
68
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
Adana, Turkey (Türkiye), 01250
Actively Recruiting
69
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
70
Ankara Bilkent Şehir Hastanesi ( Site 1801)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
71
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
Istanbul, Turkey (Türkiye), 34668
Actively Recruiting
72
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
73
Addenbrooke's Hospital ( Site 1902)
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
74
The Beatson West of Scotland Cancer Centre ( Site 1904)
Glasgow, Glasgow City, United Kingdom, G12 0YN
Actively Recruiting
75
Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
Preston, Lancashire, United Kingdom, PR2 9HT
Actively Recruiting
76
University College London Hospital ( Site 1905)
London, London, City of, United Kingdom, NW1 2PG
Actively Recruiting
77
Queen Elizabeth Hospital Birmingham ( Site 1903)
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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