A Study of Opevesostat (MK-5684) in China Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (MK-5684-001)
NCT ID: NCT06136598
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
14 participants
INTERVENTIONAL
2024-01-30
2027-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Opevesostat
Participants will receive opevesostat by oral tablets twice daily plus dexamethasone and fludrocortisone by oral tablets once daily continuously until unacceptable toxicity or documented progression. Hydrocortisone will also be provided to participants for use as rescue medication.
Opevesostat
Tablets to be taken orally.
Dexamethasone
Tablets to be taken orally
Fludrocortisone
Tablets to be taken orally.
Hydrocortisone
Tablet to be taken orally as a rescue medication.
Interventions
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Opevesostat
Tablets to be taken orally.
Dexamethasone
Tablets to be taken orally
Fludrocortisone
Tablets to be taken orally.
Hydrocortisone
Tablet to be taken orally as a rescue medication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has prostate cancer while receiving androgen deprivation therapy (ADT), or post-bilateral orchiectomy, within 6 months before screening.
* Has evidence of progression \>4 weeks since last flutamide treatment or \>6 weeks since last bicalutamide or nilutamide treatment.
* Has evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue shown by CT/MRI.
* Has disease that progressed during or after treatment with at least 1 line of next-generation hormonal agents (NHAs) for hormone-sensitive prostate cancer (HSPC) or castration-resistant prostate cancer (CRPC) for at least 8 weeks (at least 14 weeks for participants with bone progression).
* Has received at least 1 line of taxane-based chemotherapy for HSPC or CRPC and have had progressed disease during or on treatment, or refused or ineligible to receive chemotherapy.
* Has a life expectancy of \>3 months.
Exclusion Criteria
* Has presence of gastrointestinal condition, e.g. malabsorption, that might affect the adsorption of study intervention.
* Has a history of pituitary dysfunction.
* Has poorly controlled diabetes mellitus.
* Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events.
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 4 weeks of the date of allocation.
* Has received an anticancer monoclonal antibody (mAb) within 4 weeks of allocation, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of allocation.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the date of allocation.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any form of immunosuppressive therapy within 7 days prior to the start of study intervention.
* Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has a history of or current human immunodeficiency virus (HIV) infection.
* Has a concurrent Hepatitis B or Hepatitis C virus infection.
* Has a history of allogenic tissue or solid organ transplant.
18 Years
MALE
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Peking University First Hospital-Urology ( Site 0001)
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center-Neurosurgery department ( Site 0003)
Guangzhou, Guangdong, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 0002)
Wuhan, Hubei, China
Countries
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-5684-001
Identifier Type: OTHER
Identifier Source: secondary_id
5684-001
Identifier Type: -
Identifier Source: org_study_id