2023-506288-33-00招募中1/2 期
MK-5684-01A Substudy: A Phase 1/2 Umbrella Substudy of MK-5684-U01 Master Protocol to Evaluate the Safety and Efficacy of MK-5684-based Treatment Combinations or MK-5684 Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (OMAHA-01A)
干预措施
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 入组人数
- 127
- 试验地点
- 29
- 主要终点
- Number of participants who experience one or more dose-limiting toxicities (DLTs)
研究概览
简要总结
- Safety Lead-in: To evaluate the safety and tolerability, and to establish a RP2D, of treatment combinations that have not been evaluated in a separate study.
- Efficacy phase: To evaluate the safety and tolerability for each treatment arm.
- Efficacy phase: To estimate the PSA response rate for each treatment arm.
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
- •Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without small cell histology.
- •Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
- •Prostate cancer progression and received androgen deprivation therapy (ADT) or post bilateral orchiectomy within 6 months before screening.
- •Evidence of disease progression from either, >4 weeks from last flutamide treatment, or >6 weeks from last bicalutamide or nilutamide treatment, if receiving first generation anti-androgen therapy as last treatment therapy.
- •Current evidence of metastatic disease.
- •Prior treatment with 1 to 2 novel hormonal agent(s) (NHA) for non-metastatic, or metastatic, hormone-sensitive prostate cancer or castration-resistant prostate cancer and have disease progression during or after treatment.
- •Treatment with bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before randomization.
- •Participants who experienced adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline.
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- •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.
排除标准
- •History of pituitary dysfunction.
- •Is on an unstable dose of thyroid hormone therapy within 6 months prior to first dose of study intervention.
- •Received a whole blood transfusion in the last 120 days before randomization (packed red blood cells and platelet transfusions are acceptable if not given within 28 days before randomization).
- •Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- •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 does of study intervention. Administration of killed vaccines is allowed.
- •Diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy, or any other form of immunosuppressive therapy, within 7 days prior to the first dose of study intervention.
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Active autoimmune disease that has required systemic treatment in the past 2 years.
- •Active infection requiring systemic therapy.
- •Poorly controlled diabetes mellitus.
- •Concurrent active HBV or HCV infections.
- •Active or unstable cardio/cerebro-vascular disease, including thromboembolic events and history of stroke or transient ischemic attack within 6 months before the first dose of study intervention, history of myocardial infarction within 6 months before the first dose of study intervention, New York Heart Association Class III or IV cardiac disease or congestive heart failure, coronary heart disease that is symptomatic, or unstable angina
- •History or family history of long corrected QT interval (QTc) syndrome.
- •Myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or features suggestive of MDS/AML.
- •History or current condition of adrenal insufficiency.
- •History of (noninfectious) pneumonitis requiring steroids, or current pneumonitis.
- •HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
- •Undergone major surgery, including local prostate intervention (except prostate biopsy) within 28 days before randomization, and has not recovered from the toxicities and/or complications.
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Number of participants who experience one or more dose-limiting toxicities (DLTs)
Number of participants who experience one or more adverse events (AEs)
Number of participants who experience one or more adverse events (AEs)
Number of participants who discontinue study intervention due to an AE
Number of participants who discontinue study intervention due to an AE
Prostate-specific antigen (PSA) response rate
Prostate-specific antigen (PSA) response rate
次要结局
- Objective response rate (ORR)
- Radiographic progression-free survival (rPFS)
- Overall survival (OS)
- Duration of response (DOR)
- Time to first subsequent anticancer therapy (TFST)
- Time to pain progression (TTPP)
研究者
Yingjie Liu
Scientific
Merck Sharp & Dohme LLC
研究点 (29)
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