Actively Recruiting
MK-5684-01A Substudy: Safety and Efficacy of MK-5684-Based Treatment Combinations or MK-5684 Alone in Metastatic Castration-resistant Prostate Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-26
220
Participants Needed
77
Research Sites
N/A
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
Researchers are evaluating experimental treatments for metastatic castration-resistant prostate cancer (mCRPC) in this substudy 01A, which is part of a larger umbrella study. The primary aim is to assess the safety and effectiveness of combinations involving opevesostat or opevesostat alone in people with mCRPC. This substudy includes a safety lead-in phase to determine tolerability and the recommended dose, followed by an efficacy phase without formal hypothesis testing. Participants are randomly assigned to one of four treatment groups: opevesostat with dexamethasone and fludrocortisone alone; opevesostat plus olaparib with dexamethasone and fludrocortisone; opevesostat with docetaxel, prednisone, dexamethasone, and fludrocortisone; or opevesostat with cabazitaxel, prednisone, dexamethasone, and fludrocortisone. Opevesostat and dexamethasone are given orally twice or once daily, respectively, while docetaxel and cabazitaxel are given intravenously every three weeks. Treatments continue until disease progression or participant discontinuation. During the study, participants will be monitored for dose-limiting toxicities and adverse events up to about 46 months. Researchers will measure prostate-specific antigen response rates, tumor response, progression-free survival, overall survival, and other clinical outcomes. Safety and tolerability will be closely observed throughout the study period. The total duration of participation may last several years, with ongoing assessments to evaluate treatment effects and side effects.
CONDITIONS
Brief 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...
- Diagnosis of prostate adenocarcinoma confirmed by tissue tests without small cell features
- Evidence of prostate cancer progression and prior androgen deprivation therapy or bilateral orchiectomy within 6 months before screening
- Disease progression after last anti-androgen therapy (flutamide, bicalutamide, or nilutamide) with specified waiting periods
- Current presence of metastatic disease
- Prior treatment with 1 to 2 novel hormonal agents for hormone-sensitive or castration-resistant prostate cancer with progression during or after treatment
- 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 on antiretroviral therapy if HIV positive
- For Hepatitis B surface antigen positive, at least 4 weeks of antiviral therapy and undetectable viral load
- For history of Hepatitis C, undetectable viral load
You will not qualify if you...
- History of pituitary dysfunction
- Poorly controlled diabetes mellitus
- Active or unstable cardiovascular or cerebrovascular disease including recent stroke or myocardial infarction within 6 months
- History or family history of long corrected QT interval syndrome
- Myelodysplastic syndrome or acute myeloid leukemia
- History or current adrenal insufficiency
- History of or current pneumonitis requiring steroids
- HIV-infected participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Major surgery including local prostate intervention within 28 days before randomization without recovery
- Unstable thyroid hormone therapy dose within 6 months prior to first dose
- Recent whole blood transfusion within 120 days before randomization
- Prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Radiotherapy within 2 weeks of study start or related toxicities needing corticosteroids
- Live or live-attenuated vaccine within 30 days before first dose
- Immunodeficiency or immunosuppressive therapy within 7 days prior to first dose
- Another progressing malignancy requiring treatment in past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring recent systemic treatment
- Active infection needing systemic therapy
- Concurrent active Hepatitis B or C infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 46 months
Participants receive study drug combinations including oral tablets and intravenous infusions until disease progression or discontinuation.
Visits every 3 weeks for IV infusions plus regular oral medication intake
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
Active, Not 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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here