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)
NCT ID: NCT06353386
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
220 participants
INTERVENTIONAL
2024-05-20
2029-01-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A1: Opevesostat
Participants receive 5 mg of opevesostat twice daily (BID) via oral tablet plus dexamethasone 1.5 mg by oral tablets once daily (QD) and 0.1 mg fludrocortisone acetate by oral tablet QD until progression or discontinuation.
Opevesostat
Oral Tablet
Fludrocortisone acetate
Oral Tablet
Dexamethasone
Oral Tablet
Arm A2: Olaparib + Opevesostat
Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 300 mg of olaparib BID via oral tablet until progressive disease or discontinuation.
Opevesostat
Oral Tablet
Olaparib
Oral Tablet
Fludrocortisone acetate
Oral Tablet
Dexamethasone
Oral Tablet
Arm A3: Docetaxel + Opevesostat
Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 75 mg/m\^2 of docetaxel once every 3 weeks (Q3W) via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
Opevesostat
Oral Tablet
Docetaxel
IV Infusion
Fludrocortisone acetate
Oral Tablet
Dexamethasone
Oral Tablet
Prednisone
Oral Tablet
Arm A4: Cabazitaxel + Opevesostat
Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 20 mg/m\^2 of cabazitaxel Q3W via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
Opevesostat
Oral Tablet
Cabazitaxel
IV Infusion
Fludrocortisone acetate
Oral Tablet
Dexamethasone
Oral Tablet
Prednisone
Oral Tablet
Interventions
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Opevesostat
Oral Tablet
Olaparib
Oral Tablet
Docetaxel
IV Infusion
Cabazitaxel
IV Infusion
Fludrocortisone acetate
Oral Tablet
Dexamethasone
Oral Tablet
Prednisone
Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
* Evidence of disease progression from either, \>4 weeks from last flutamide treatment, or \>6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
* Current evidence of metastatic disease.
* Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
* Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for \>4 weeks before randomization.
* Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to \<Grade 1 or baseline.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load.
* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion Criteria
* Poorly controlled diabetes mellitus.
* Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
* History or family history of long corrected QT interval (QTc) syndrome.
* Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
* History or current condition of adrenal insufficiency.
* History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
* Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
* Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities, requiring corticosteroids.
* Received a live or live-attenuated vaccine within 30 days before the first does of study intervention. Administration of killed vaccines is allowed.
* Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* Active infection requiring systemic therapy.
* Concurrent active HBV or HCV infections.
18 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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UCSD Moores Cancer Center ( Site 0039)
La Jolla, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
Los Angeles, California, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
Miami, Florida, United States
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
Baltimore, Maryland, 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
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
Milwaukee, Wisconsin, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
Macquarie University, New South Wales, Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
Greenslopes, Queensland, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)
Melbourne, Victoria, Australia
Centre Hospitalier de l'Université de Montréal ( Site 0200)
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0206)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
Québec, Quebec, Canada
Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
Talca, Maule Region, Chile
FALP ( Site 0301)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0303)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0300)
Santiago, Region M. de Santiago, Chile
CIDO SpA-Oncology ( Site 0302)
Temuco, Región del Biobío, Chile
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
Bogotá, Bogota D.C., Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
Valledupar, Cesar Department, Colombia
IMAT S.A.S ( Site 0404)
Montería, Departamento de Córdoba, Colombia
Fundación Valle del Lili-Oncology CIC ( Site 0403)
Cali, Valle del Cauca Department, Colombia
Herlev and Gentofte Hospital ( Site 0501)
Copenhagen, Capital Region, Denmark
Aalborg Universitetshospital, Syd ( Site 0503)
Aalborg, North Denmark, Denmark
Vaasan Keskussairaala ( Site 0603)
Vaasa, Pohjanmaa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
Helsinki, Uusimaa, Finland
Docrates Syöpäsairaala ( Site 0602)
Helsinki, Uusimaa, Finland
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0700)
Strasbourg, Alsace, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
Bordeaux, Aquitaine, France
Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
Paris, , France
Gustave Roussy ( Site 0701)
Villejuif, Île-de-France Region, France
Universitaetsklinikum Heidelberg ( Site 0805)
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
Tübingen, Baden-Wurttemberg, Germany
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
Munich, Bavaria, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
Hamburg, , Germany
St. Vincent's University Hospital ( Site 0901)
Dublin, Dublin, Ireland
Cork University Hospital ( Site 0902)
Cork, , Ireland
Tallaght University Hospital ( Site 0900)
Dublin, , Ireland
Rambam Health Care Campus-Oncology Division ( Site 1002)
Haifa, , Israel
Rabin Medical Center ( Site 1001)
Petah Tikva, , Israel
Sheba Medical Center ( Site 1000)
Ramat Gan, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
Milan, Lombardy, Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
Rozzano, Milano, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedal-Centro Ricerche Cliniche di Verona ( Site 1100)
Verona, , Italy
Toho University Sakura Medical Center ( Site 1201)
Sakura, Chiba, Japan
Yokohama City University Medical Center ( Site 1203)
Yokohama, Kanagawa, Japan
The Jikei University Hospital ( Site 1202)
Mitato, Tokyo, Japan
Kyushu University Hospital ( Site 1204)
Fukuoka, , Japan
Auckland City Hospital ( Site 1333)
Auckland, , New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1402)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 1405)
Gdansk, Pomeranian Voivodeship, Poland
Asan Medical Center-Oncology ( Site 1500)
Songpagu, Seoul, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
Seoul, , South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
Seoul, , South Korea
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
Barcelona, , Spain
Hospital General Universitario Gregorio Marañón ( Site 1601)
Madrid, , Spain
Hospital Clinico San Carlos-Oncology Department ( Site 1604)
Madrid, , Spain
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
China Medical University Hospital ( Site 1703)
Taichung, , Taiwan
Taipei Veterans General Hospital ( Site 1701)
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
Taoyuan District, , Taiwan
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
Adana, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi ( Site 1801)
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
Istanbul, , Turkey (Türkiye)
Addenbrooke's Hospital ( Site 1902)
Cambridge, Cambridgeshire, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1904)
Glasgow, Glasgow City, United Kingdom
Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
Preston, Lancashire, United Kingdom
University College London Hospital ( Site 1905)
London, London, City of, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 1903)
Birmingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-5684-01A
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506288-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1292-6912
Identifier Type: REGISTRY
Identifier Source: secondary_id
jRCT2031240224
Identifier Type: REGISTRY
Identifier Source: secondary_id
5684-01A
Identifier Type: -
Identifier Source: org_study_id