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MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)

Status
Suspended
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504957-11-00
Acronym
MK-5684-004
Enrollment
401
Registered
2024-03-19
Start date
2024-04-05
Completion date
Unknown
Last updated
2025-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration resistant prostate cancer

Brief summary

Radiographic Progression-free Survival (rPFS), Overall Survival (OS)

Detailed description

Time to Initiation of the First Subsequent Anticancer Therapy (TFST), Objective Response Rate (ORR), Duration of Response (DOR), Time to Pain Progression (TTPP), Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score, Time to Deterioration (TTD) in FACT-G Total Score, Overall Improvement in FACT-G Total Score, Time to Prostate-specific Antigen (PSA) progression, Prostate-specific Antigen (PSA) Response Rate, Time to first symptomatic skeletal-related event (TSSRE), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Interventions

DRUGDEXAMETHASONE
DRUGABIRATERONE ACETATE
DRUGHYDROCORTISONE
DRUGPREDNISONE
DRUGFLUDROCORTISONE
DRUGPREDNISOLONE
DRUGENZALUTAMIDE

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Radiographic Progression-free Survival (rPFS), Overall Survival (OS)

Secondary

MeasureTime frame
Time to Initiation of the First Subsequent Anticancer Therapy (TFST), Objective Response Rate (ORR), Duration of Response (DOR), Time to Pain Progression (TTPP), Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score, Time to Deterioration (TTD) in FACT-G Total Score, Overall Improvement in FACT-G Total Score, Time to Prostate-specific Antigen (PSA) progression, Prostate-specific Antigen (PSA) Response Rate, Time to first symptomatic skeletal-related event (TSSRE), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE

Countries

Czechia, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Portugal, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026