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) (OMAHA-01A)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506288-33-00

Acronym

MK-5684-01A

Enrollment

127

Registered

2024-07-23

Start date

2025-03-03

Completion date

Unknown

Last updated

2026-01-27

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 (mCRPC)

Brief summary

Number of participants who experience one or more dose-limiting toxicities (DLTs), Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study intervention due to an AE, Prostate-specific antigen (PSA) response rate

Detailed description

Objective response rate (ORR), Radiographic progression-free survival (rPFS), Overall survival (OS), Duration of response (DOR), Time to first subsequent anticancer therapy (TFST), Time to pain progression (TTPP)

Interventions

DRUGFLUDROCORTISONE

DRUG-

DRUGCABAZITAXEL

DRUGDOCETAXEL

DRUGOpevesostat

DRUGOlaparib

DRUGHYDROCORTISONE

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of participants who experience one or more dose-limiting toxicities (DLTs), Number of participants who experience one or more adverse events (AEs), Number of participants who discontinue study intervention due to an AE, Prostate-specific antigen (PSA) response rate	—

Secondary

Measure	Time frame
Objective response rate (ORR), Radiographic progression-free survival (rPFS), Overall survival (OS), Duration of response (DOR), Time to first subsequent anticancer therapy (TFST), Time to pain progression (TTPP)	—

Countries

Denmark, Finland, France, Germany, Ireland, Italy, Poland, Spain

Outcome results

None listed

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