A clinical trial comparing a new treatment (MK-5684) to approved medication for advanced prostate cancer after prior hormonal therapy and chemotherapy
- Conditions
- Metastatic castration resistant prostate cancerMedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504899-25-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 1246
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology, Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated, Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART), Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization, Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization., Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening., Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening, If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression >4 weeks since the last flutamide treatment and >6 weeks since the last bicalutamide or nilutamide treatment, 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 disease that progressed during or after treatment with 1 novel hormonal agent (NHA), Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment, Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<1.7 nM), Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for = 4 weeks before the date of randomization, 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 MK-5684, for at least 30 days after the last dose of abiraterone acetate, and for at least 30 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom.
Has a gastrointestinal disorder that might affect absorption, Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications, Participants who have not adequately recovered from major surgery or have ongoing surgical complications, Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate) within 4 weeks before the date of randomization, Has received radium-223 or lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade =1 or baseline from AEs due to radium-223 or lutetium-177 administered more than 4 weeks before the date of randomization, Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures, Has received treatment with 5-areductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization, Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention, Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention, Has received colony-stimulating factors within 28 days before the date of randomization, Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization., Unable to swallow capsules/tablets, Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks, Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention, Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids, Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention, Has a superscan” bone scan, Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication, Known additional malignancy that is progressing or has required active treatment within the past 3 years, Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis, Has an active autoimmune disease that has required systemic treatment in past 2 years, Has an active infection requiring systemic therapy, History of pituitary dysfunction, Has concurrent active HBV or known active HCV infection, Poorly controlled diabetes mellitus, Clinically significant abnormal serum potassium or sodium level, Has active or unstable cardio/cerebro-vascular disease, including thromboembolic events, Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization, Has a history of clinically significant ventricular arrhythmias, Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of ran
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method