2023-504957-11-00招募中3 期
MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 401
- 试验地点
- 75
- 主要终点
- Radiographic Progression-free Survival (rPFS)
研究概览
简要总结
- To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to rPFS per PCWG Modified RECIST 1.1, as assessed by BICR in participants with mCRPC.
- To compare MK-5684 to alternative abiraterone acetate or enzalutamide with respect to overall survival in participants with mCRPC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
- •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
- •Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy (HRT) or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (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 shown by computed tomography scan (CT)/magnetic resonance imaging (MRI)
- •Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) metastatic hormone sensitive prostate cancer (mHSPC) or nonmetastatic hormone sensitive prostate cancer (nmHSPC), or castration-resistant prostate cancer (CRPC) metastatic castration-resistant prostate cancer (mCRPC) or non-metastatic castration-resistant prostate cancer (nmCRPC) for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression) Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than six cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
- •Has had prior treatment with Poly polymerase inhibitors (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
- •Has ongoing androgen deprivation therapy (ADT) with serum testosterone <50 ng/dL (<1.7 nM)
- •Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
- •Has adequate organ function
- •Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
排除标准
- •Has presence of gastrointestinal condition
- •Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
- •Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
- •Has not adequately recovered from major surgery or have ongoing surgical complications
- •Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
- •Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
- •Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
- •Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- •Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
- •Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
- •Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- •Is unable to swallow capsules/tablets
- •Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- •Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or MK-5684
- •Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
- •Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- •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 the first dose of study medication
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
- •Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
- •Active infection requiring systemic therapy
- •Has concurrent active Hepatitis B virus and Hepatitis C virus infection
- •Has history of pituitary dysfunction
- •Has poorly controlled diabetes mellitus
- •Has clinically significant abnormal serum potassium or sodium level.
- •Has any of the following at Screening Visit: Hypotension: systolic blood pressure (BP) <110 mmHg, or Uncontrolled hypertension: systolic BP >160mmHg or diastolic blood BP >90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
- •Has history or family history of long QTc syndrome
- •Has a history of seizure(s) within 6 months prior to signing the informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
- •Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
结局指标
主要结局
Radiographic Progression-free Survival (rPFS)
Radiographic Progression-free Survival (rPFS)
Overall Survival (OS)
Overall Survival (OS)
次要结局
- Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Time to Pain Progression (TTPP)
- Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Total Score
- Time to Deterioration (TTD) in FACT-G Total Score
- Overall Improvement in FACT-G Total Score
- Time to Prostate-specific Antigen (PSA) progression
- Prostate-specific Antigen (PSA) Response Rate
- Time to first symptomatic skeletal-related event (TSSRE)
- Number of Participants Who Experience an Adverse Event (AE)
- Number of Participants Who Discontinue Study Treatment Due to an AE
研究者
Jelena Todoric
Scientific
Merck Sharp & Dohme LLC
研究点 (75)
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