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RECRUITING

NCT06353386

PHASE1/PHASE2

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Official title: MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2024-05-20

Completion Date

2029-01-15

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

DRUG

Opevesostat

Oral Tablet

DRUG

Olaparib

Oral Tablet

DRUG

Docetaxel

IV Infusion

DRUG

Cabazitaxel

IV Infusion

DRUG

Fludrocortisone acetate

Oral Tablet

DRUG

Dexamethasone

Oral Tablet

DRUG

Prednisone

Oral Tablet

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.

Locations (77)

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

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (77)