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Be Part of Research - Trial Details - A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
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A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Recruiting

Open to: ALL

Age: 18.0 - N/A

Truro London Manchester Cambridge Glasgow London Torquay Windsor Derby London London Northwood Oxford

Medical Conditions

Prostatic Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2023 Dec 2030

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : hormone replacement therapy (HRT)+ opevesostat;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : hormone replacement therapy (HRT)+ opevesostat;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : hormone replacement therapy (HRT)+ opevesostat;

Intervention Type : DRUG
Intervention Description : Administered orally or IM as a rescue drug

Intervention Arm Group : hormone replacement therapy (HRT)+ opevesostat;

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Alternative next generation hormonal agent (NHA);

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Alternative next generation hormonal agent (NHA);

Intervention Type : DRUG
Intervention Description : Administered orally

Intervention Arm Group : Alternative next generation hormonal agent (NHA);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Cornwall Hospital ( Site 1430)
    Truro
    England
    TR1 3LJ
  • Charing Cross Hospital-Oncology Research ( Site 1434)
    London
    Hammersmith And Fulham
    W6 8RF
  • The Christie NHS Foundation Trust ( Site 1436)
    Manchester
    m20 4bx
  • Addenbrooke's Hospital ( Site 1426)
    Cambridge
    Cambridgeshire
    CB2 2QQ
  • The Beatson West of Scotland Cancer Centre ( Site 1428)
    Glasgow
    Glasgow City
    G12 0YN
  • University College London Hospital ( Site 1437)
    London
    London, City Of
    NW1 2PG
  • Torbay Hospital ( Site 1429)
    Torquay
    Devon
    TQ2 7AA
  • GenesisCare - Windsor ( Site 1443)
    Windsor
    Windsor And Maidenhead
    SL4 3HD
  • Royal Derby Hospital ( Site 1431)
    Derby
    Derbyshire
    DE22 3NE
  • St. George's Hospital-Oncology ( Site 1441)
    London
    London, City Of
    SW17 0QT
  • Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435)
    London
    London, City Of
    SE1 9RT
  • Mount Vernon Cancer Centre ( Site 1440)
    Northwood
    England
    HA6 2RN
  • GenesisCare - Oxford ( Site 1442)
    Oxford
    Oxfordshire
    OX4 6LB

Toll Free Number 1-888-577-8839
Trialsites@msd.com



The study is sponsored by Merck Sharp & Dohme LLC and is in collaboration with Orion Corporation, Orion Pharma.




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Read full details for Trial ID: NCT06136650
Last updated 09 April 2025

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