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Be Part of Research - Trial Details - 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)
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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)

Recruiting

Open to: ALL

Age: 18.0 - N/A

Glasgow Cambridge Preston London Birmingham

Medical Conditions

Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant

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.


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.

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:

May 2024 Mar 2028

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Oral Tablet

Intervention Arm Group : Arm A1: Opevesostat;Arm A2: Olaparib + Opevesostat;Arm A3: Docetaxel + Opevesostat;Arm A4: Cabazitaxel + Opevesostat;

Intervention Type : DRUG
Intervention Description : Oral Tablet

Intervention Arm Group : Arm A2: Olaparib + Opevesostat;

Intervention Type : DRUG
Intervention Description : IV Infusion

Intervention Arm Group : Arm A3: Docetaxel + Opevesostat;

Intervention Type : DRUG
Intervention Description : IV Infusion

Intervention Arm Group : Arm A4: Cabazitaxel + Opevesostat;

Intervention Type : DRUG
Intervention Description : Oral Tablet

Intervention Arm Group : Arm A1: Opevesostat;Arm A2: Olaparib + Opevesostat;Arm A3: Docetaxel + Opevesostat;Arm A4: Cabazitaxel + Opevesostat;

Intervention Type : DRUG
Intervention Description : Oral Tablet

Intervention Arm Group : Arm A1: Opevesostat;Arm A2: Olaparib + Opevesostat;Arm A3: Docetaxel + Opevesostat;Arm A4: Cabazitaxel + Opevesostat;

Intervention Type : DRUG
Intervention Description : Oral Tablet

Intervention Arm Group : Arm A3: Docetaxel + Opevesostat;Arm A4: Cabazitaxel + Opevesostat;



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 Beatson West of Scotland Cancer Centre ( Site 1904)
    Glasgow
    Glasgow City
    G12 0YN
  • Addenbrooke's Hospital ( Site 1902)
    Cambridge
    Cambridgeshire
    CB2 2QQ
  • Royal Preston Hospital-Lancashire Clinical Research Facility ( Site 1900)
    Preston
    Lancashire
    PR2 9HT
  • University College London Hospital ( Site 1905)
    London
    London, City Of
    NW1 2PG
  • Queen Elizabeth Hospital Birmingham ( Site 1903)
    Birmingham
    Warwickshire
    B15 2TH

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: NCT06353386
Last updated 08 May 2025

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