Phase 1/2Recruiting
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)
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)
- Sponsor
- Merck Sharp & Dohme LLC (Industry)
- Enrolment
- 220 planned
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Opevesostat; Olaparib; Docetaxel; Cabazitaxel; Fludrocortisone acetate; Dexamethasone; Prednisone
- Ages
- adults, older adults
- Registry
- NCT06353386, CTIS2023-506288-33-00, jRCT2031240224
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- 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
History
Primary completion expected
Last registry update
Started
Registered