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Clinical Trials in Ireland / NCT06353386
Recruiting Phase 1/Phase 2

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)

NCT06353386 · tracked via the Priya Life Science Ireland tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1/Phase 2
Started
2024-05-20
Last updated
2026-09-03

Condition(s) studied

Prostatic Neoplasms, Castration-Resistant

Investigational drug(s) / intervention(s)

OpevesostatOlaparibDocetaxelCabazitaxelFludrocortisone acetateDexamethasonePrednisone

Opevesostat: Oral Tablet

Olaparib: Oral Tablet

Docetaxel: IV Infusion

Cabazitaxel: IV Infusion

Fludrocortisone acetate: Oral Tablet

Dexamethasone: Oral Tablet

Prednisone: Oral Tablet

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology. * 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: The main exclusion criteria include but are not limited to the following: * History of pituitary dysfunction. * 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.

Primary outcome measure(s)

Trial sites (77)

FacilityCityRegionStatus
UCSD Moores Cancer Center ( Site 0039) La Jolla California Recruiting
UCLA Hematology/Oncology - Santa Monica ( Site 0044) Los Angeles California Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051) Miami Florida Recruiting
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore Maryland Active Not Recruiting
Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick New Jersey Active Not Recruiting
University Hospitals Cleveland Medical Center ( Site 0043) Cleveland Ohio Recruiting
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020) Milwaukee Wisconsin Recruiting
Macquarie University-MQ Health Clinical Trials Unit ( Site 0108) Macquarie University New South Wales Recruiting
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107) Greenslopes Queensland Recruiting
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110) Melbourne Victoria Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0200) Montreal Quebec Recruiting
Jewish General Hospital ( Site 0206) Montreal Quebec Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207) Québec Quebec Recruiting
CIDO SpA-Oncology ( Site 0302) Temuco Biobio Active Not Recruiting
Clinica Universidad Catolica del Maule-Oncology ( Site 0304) Talca Maule Region Recruiting
FALP ( Site 0301) Santiago Region M. de Santiago Active Not Recruiting
Pontificia Universidad Catolica de Chile ( Site 0303) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 0300) Santiago Region M. de Santiago Recruiting
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406) Bogotá Bogota D.C. Recruiting
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402) Bogotá Bogota D.C. Recruiting
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400) Valledupar Cesar Department Recruiting
IMAT S.A.S ( Site 0404) Montería Departamento de Córdoba Recruiting
Fundación Valle del Lili-Oncology CIC ( Site 0403) Cali Valle del Cauca Department Recruiting
Herlev and Gentofte Hospital ( Site 0501) Copenhagen Capital Region Recruiting
Aalborg Universitetshospital, Syd ( Site 0503) Aalborg North Denmark Recruiting
Vaasan Keskussairaala ( Site 0603) Vaasa Pohjanmaa Recruiting
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604) Helsinki Uusimaa Recruiting
Docrates Syöpäsairaala ( Site 0602) Helsinki Uusimaa Recruiting
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703) Bordeaux Aquitaine Recruiting
Hopitaux Universitaires de Strasbourg ( Site 0700) Strasbourg Bas-Rhin Recruiting
Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702) Paris France Recruiting
Gustave Roussy ( Site 0701) Villejuif Île-de-France Region Recruiting
Universitaetsklinikum Heidelberg ( Site 0805) Heidelberg Baden-Wurttemberg Recruiting
Universitaetsklinikum Tuebingen-Urologie ( Site 0801) Tübingen Baden-Wurttemberg Recruiting
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802) Munich Bavaria Recruiting
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800) Berlin Germany Active Not Recruiting
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804) Hamburg Germany Recruiting
St. Vincent's University Hospital ( Site 0901) Dublin Dublin Recruiting
Cork University Hospital ( Site 0902) Cork Ireland Recruiting
Tallaght University Hospital ( Site 0900) Dublin Ireland Recruiting

+ 37 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06353386 on ClinicalTrials.gov ↗ ← All trials in Ireland