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)

Conditions

• Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Opevesostat — DRUG
  Oral Tablet
• Olaparib — DRUG
  Oral Tablet
• Docetaxel — DRUG
  IV Infusion
• Cabazitaxel — DRUG
  IV Infusion
• Fludrocortisone acetate — DRUG
  Oral Tablet
• Dexamethasone — DRUG
  Oral Tablet
• Prednisone — DRUG
  Oral Tablet

Study Details

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.

Key Dates

Start date

May 20, 2024

Status verified

May 2026

Primary completion

Jan 15, 2029

Completion

Jan 15, 2029

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A1: Opevesostat
  Participants receive 5 mg of opevesostat twice daily (BID) via oral tablet plus dexamethasone 1.5 mg by oral tablets once daily (QD) and 0.1 mg fludrocortisone acetate by oral tablet QD until progression or discontinuation.
• Experimental: Arm A2: Olaparib + Opevesostat
  Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 300 mg of olaparib BID via oral tablet until progressive disease or discontinuation.
• Experimental: Arm A3: Docetaxel + Opevesostat
  Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 75 mg/m\^2 of docetaxel once every 3 weeks (Q3W) via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.
• Experimental: Arm A4: Cabazitaxel + Opevesostat
  Participants receive 5 mg of opevesostat BID via oral tablet plus dexamethasone 1.5 mg by oral tablets QD and 0.1 mg fludrocortisone acetate by oral tablet QD, PLUS 20 mg/m\^2 of cabazitaxel Q3W via IV infusion, plus prednisone per approved product label BID by oral tablets until progressive disease or discontinuation.

Primary Outcome Measure

Number of participants who experience one or more dose-limiting toxicities (DLTs) [ Time Frame: Up to approximately 28 days ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (7)

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