a study of opevesostat (mk-568)4 in japanese participants with metastatic castration-resistant prostate cancer (mcrpc) (mk-5684-005)

Conditions: Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer

Summary: the purpose of this study is to assess the efficacy and safety of opevesostat in the treatment of japanese men with metastatic castration-resistant prostate cancer (mcrpc) previously treated with next generation hormonal agent (nha) and taxane-based chemotherapy.


Eligibility criteria:
the main inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology * has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (ct/mri) * has ongoing androgen deprivation with serum testosterone \<50 ng/dl (\<1.7 nmol/l) * participants receiving bone anti-resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks prior to the start of study intervention. * has progressed on or after treatment with at least 1 line of nhas in metastatic hormone-sensitive prostate cancer (mhspc) or in castration-resistant prostate cancer (crpc) for a minimum of 12 weeks (e.g. abiraterone, enzalutamide, darolutamide, apalutamide), and with at least 1 line of taxane-based chemotherapy in mhspc or in crpc, or ineligibility for chemotherapy * has an eastern cooperative oncology group (ecog) performance status of 0 or 1 within 10 days prior to allocation * if capable of producing sperm, participant must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat: refrain from donating sperm, plus either be abstinent or must agree to use male condom. exclusion criteria: * has a history of pituitary dysfunction * has brain metastases * history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years * has an active or uncontrolled autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) * has an active infection or other medical condition that would make corticosteroid contraindicated * has serious persistent infection within 2 weeks prior to the start of the study intervention * participants on an unstable dose of thyroid hormone therapy within 6 months prior to the start of the study intervention * has poorly controlled diabetes mellitus * hypotension: systolic blood pressure (bp) \< 110 mmhg, or uncontrolled hypertension: systolic bp ≥ 160 mmhg or diastolic bp ≥ 95 mmhg, in 2 out of 3 recordings with optimized antihypertensive therapy * has active or unstable cardio/cerebro-vascular disease, including thromboembolic event * is unable to swallow orally administered medication or known gastrointestinal (gi) disease or gi procedure that may interfere with absorption of study intervention * has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to the start of the study intervention and not adequately recovered from the toxicities and/or complications * has received aldosterone antagonist (e.g. spironolactone, eplerenone) and phenytoin within 4 weeks prior to the start of the study intervention * has received radiotherapy within 4 weeks prior to the start of the study intervention, or radiation related toxicities, requiring corticosteroids * has received chemotherapy within the last 4 weeks (2 weeks for oral or weekly chemotherapy; 6 weeks for nitrosoureas and mitomycin c) prior to the start of the study intervention * has received prior enzalutamide and apalutamide within 3 weeks, or abiraterone and darolutamide within 2 weeks prior to the start of the study intervention * systemic use of the following medications within 2 weeks prior to the start of study intervention: strong cytochrome p450 (cyp)3a4 inducers: e.g., carbamazepine, rifampicin, phenobarbital, phenytoin, st john's wort) and strong cyp3a4 inhibitors: e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, grapefruit juice * received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. administration of killed vaccines are allowed. * has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease psa levels (eg, saw palmetto) within 4 weeks prior to the start of the study intervention * has received treatment with 5-α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to the start of the study intervention * has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * history of human immunodeficiency virus (hiv) infection * has a history of hepatitis b or active hepatitis c virus * has a "superscan" bone scan * has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the start of the study intervention