RecruitingPhase 1Phase 2NCT06353386

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)

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

220 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Prostatic Neoplasms, Castration-Resistant

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called opevesostat (MK-5684), alone or combined with other treatments, for men with prostate cancer that has spread to other parts of the body and is no longer responding to hormone therapy. It aims to find new ways to control this advanced form of prostate cancer. **You may be eligible if...** - You have been confirmed to have prostate cancer (adenocarcinoma) that has spread (metastatic) - Your cancer has continued to grow despite hormone-reducing therapy or surgical removal of the testicles - You have already tried 1–2 newer hormone-blocking drugs (such as enzalutamide or abiraterone) and your cancer has progressed - You have well-controlled HIV, hepatitis B, or hepatitis C (with undetectable virus levels) **You may NOT be eligible if...** - You have a history of pituitary gland problems - You have poorly controlled diabetes - You have had a stroke, heart attack, or serious heart condition in the past 6 months - You have or are suspected to have a bone marrow disorder (MDS or AML) - You have a personal or family history of a heart rhythm condition called long QT syndrome Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOpevesostat

Oral Tablet

DRUGOlaparib

Oral Tablet

DRUGDocetaxel

IV Infusion

DRUGCabazitaxel

IV Infusion

DRUGFludrocortisone acetate

Oral Tablet

DRUGDexamethasone

Oral Tablet

DRUGPrednisone

Oral Tablet

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

CIDO SpA-Oncology ( Site 0302)

Temuco, Biobio, Chile

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

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 Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)

Bordeaux, Aquitaine, France

Hopitaux Universitaires de Strasbourg ( Site 0700)

Strasbourg, Bas-Rhin, 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, 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

View Full Details on ClinicalTrials.gov

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NCT06353386

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