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)

Status: Recruiting
Location: See all (77) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
California
UCSD Moores Cancer Center ( Site 0039)
RECRUITING
La Jolla
UCLA Hematology/Oncology - Santa Monica ( Site 0044)
RECRUITING
Los Angeles
Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 0051)
RECRUITING
Miami
Maryland
University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 0049)
RECRUITING
Baltimore
New Jersey
Rutgers Cancer Institute of New Jersey ( Site 0033)
RECRUITING
New Brunswick
Ohio
University Hospitals Cleveland Medical Center ( Site 0043)
RECRUITING
Cleveland
Wisconsin
MEDICAL COLLEGE OF WISCONSIN-Cancer Center Clinical Trials Office ( Site 0020)
RECRUITING
Milwaukee
Other Locations
Australia
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107)
RECRUITING
Greenslopes
Macquarie University-MQ Health Clinical Trials Unit ( Site 0108)
RECRUITING
Macquarie University
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110)
RECRUITING
Melbourne
Canada
Centre Hospitalier de l'Université de Montréal ( Site 0200)
RECRUITING
Montreal
Jewish General Hospital ( Site 0206)
RECRUITING
Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0207)
RECRUITING
Québec
Chile
Bradfordhill ( Site 0300)
RECRUITING
Santiago
FALP ( Site 0301)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 0303)
RECRUITING
Santiago
Clinica Universidad Catolica del Maule-Oncology ( Site 0304)
RECRUITING
Talca
CIDO SpA-Oncology ( Site 0302)
RECRUITING
Temuco
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0402)
RECRUITING
Bogotá
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0406)
RECRUITING
Bogotá
IMAT S.A.S ( Site 0404)
RECRUITING
Montería
Fundación Valle del Lili-Oncology CIC ( Site 0403)
RECRUITING
Santiago De Cali
Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0400)
RECRUITING
Valledupar
Denmark
Aalborg Universitetshospital, Syd ( Site 0503)
RECRUITING
Aalborg
Herlev and Gentofte Hospital ( Site 0501)
RECRUITING
Copenhagen
Finland
Docrates Syöpäsairaala ( Site 0602)
RECRUITING
Helsinki
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0604)
RECRUITING
Helsinki
Vaasan Keskussairaala ( Site 0603)
RECRUITING
Vaasa
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0703)
RECRUITING
Bordeaux
Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0702)
RECRUITING
Paris
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0700)
RECRUITING
Strasbourg
Gustave Roussy ( Site 0701)
RECRUITING
Villejuif
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0800)
RECRUITING
Berlin
Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0804)
RECRUITING
Hamburg
Universitaetsklinikum Heidelberg ( Site 0805)
RECRUITING
Heidelberg
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0802)
RECRUITING
Munich
Universitaetsklinikum Tuebingen-Urologie ( Site 0801)
RECRUITING
Tübingen
Ireland
Cork University Hospital ( Site 0902)
RECRUITING
Cork
St. Vincent's University Hospital ( Site 0901)
RECRUITING
Dublin
Tallaght University Hospital ( Site 0900)
RECRUITING
Dublin
Israel
Rambam Health Care Campus-Oncology Division ( Site 1002)
RECRUITING
Haifa
Rabin Medical Center ( Site 1001)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1000)
RECRUITING
Ramat Gan
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1103)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1102)
RECRUITING
Rome
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1101)
RECRUITING
Rozzano
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 1100)
RECRUITING
Verona
Japan
Kyushu University Hospital ( Site 1204)
RECRUITING
Fukuoka
The Jikei University Hospital ( Site 1202)
COMPLETED
Mitato
Toho University Sakura Medical Center ( Site 1201)
RECRUITING
Sakura
Yokohama City University Medical Center ( Site 1203)
RECRUITING
Yokohama
New Zealand
Auckland City Hospital ( Site 1333)
RECRUITING
Auckland
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1402)
RECRUITING
Bydgoszcz
Uniwersyteckie Centrum Kliniczne ( Site 1405)
RECRUITING
Gdansk
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1400)
RECRUITING
Warsaw
Republic of Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 1501)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1502)
RECRUITING
Seoul
Asan Medical Center-Oncology ( Site 1500)
RECRUITING
Songpagu
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1602)
RECRUITING
Barcelona
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 1603)
RECRUITING
L'hospitalet De Llobregat
Hospital Clinico San Carlos-Oncology Department ( Site 1604)
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón ( Site 1601)
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1600)
RECRUITING
Madrid
Taiwan
Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1704)
RECRUITING
Kaohsiung Niao Sung Dist
China Medical University Hospital ( Site 1703)
RECRUITING
Taichung
Taipei Veterans General Hospital ( Site 1701)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1702)
RECRUITING
Taoyuan District
Turkey
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1802)
RECRUITING
Adana
Ankara Bilkent Şehir Hastanesi ( Site 1801)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1800)
RECRUITING
Ankara
Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1804)
RECRUITING
Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1803)
RECRUITING
Istanbul
United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 1903)
RECRUITING
Birmingham
Addenbrooke's Hospital ( Site 1902)
RECRUITING
Cambridge
The Beatson West of Scotland Cancer Centre ( Site 1904)
RECRUITING
Glasgow
University College London Hospital ( Site 1905)
RECRUITING
London
Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
RECRUITING
Preston
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 220
Treatments
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Orion Corporation, Orion Pharma
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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