Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
ConditionProstate Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMerck Sharp & Dohme LLC
About this trial
This is a phase 3, randomized, open-label study of opevesostat compared to alternative abiraterone acetate or enzalutamide in participants with metastatic castration-resistant prostate cancer (mCRPC) with respect to overall survival (OS) in participants with mCRPC previously treated with next-generation hormonal agent (NHA) and taxane-based chemotherapy. It is hypothesized that opevesostat is superior with respect to OS in androgen receptor ligand binding domain (AR LBD) mutation-negative and -positive participants.
Eligibility criteria
Qualifiers
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
Disqualifiers
Has a gastrointestinal disorder that might affect absorption
Has a history of pituitary dysfunction
Has poorly controlled diabetes mellitus
Has clinically significant abnormal serum potassium or sodium level
Trial design
Treatments tested in this trial
- Opevesostat
- Abiraterone acetate
- Enzalutamide
- Hydrocortisone
- Fludrocortisone acetate
- Prednisone
- Dexamethasone
Treatment groups
1,310 Participants
are divided into 2 treatment groupsSponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Orion Corporation, Orion Pharma
Collaborator
Source ClinicalTrials.gov