NL-OMON54503已完成3 期
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants with Metastatic Castration resistant Prostate Cancer (mCRPC) Who are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment with One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010) - MK7339-010
Farmaceutische Industrie0 个研究点目标入组 56 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Have histologically or cytologically confirmed adenocarcinoma of the
- •prostate without small cell histology. The diagnosis must be stated in a
- •pathology report and confirmed by the investigator. 2. Have prostate cancer
- •progression while receiving androgen deprivation therapy (or post bilateral
- •orchiectomy) within 6 months before screening, as determined by the
- •investigator 3. Have disease progression under the following conditions if the
- •participant received anti-androgen therapy before screening: •*Evidence of
- •progression >4 weeks since the last flutamide treatment. •*Evidence of
- •progression >6 weeks since the last bicalutamide or nilutamide treatment. 4.
- •Have current evidence of metastatic disease documented by bone lesions on bone
- •scan and/or soft tissue disease shown by CT/MRI. 5. Have received prior
- •treatment with abiraterone acetate OR enzalutamide, but not both. 6. Have
- •received docetaxel chemotherapy regimen for mCRPC and have had PD during or
- •after treatment with docetaxel. If docetaxel chemotherapy has been used more
- •than once it will be considered as 1 therapy. Prior docetaxel for mCRPC is
- •allowed if >=4 weeks have elapsed from the last dose of docetaxel before Day 1
- •of Cycle 1. 7. Have ongoing androgen deprivation with serum testosterone <50
- •ng/dL (<2.0 nM). If the participant is currently being treated with
- •luteinizing hormone-releasing hormone (LHRH) agonists or antagonists (in
- •participants who have not undergone orchiectomy), this therapy must have been
- •initiated at least 4 weeks before the date of randomization, and treatment must
- •be continued throughout the study. 8. If receiving bone resorptive therapy,
- •including but not limited to bisphosphonates or denosumab, have been receiving
- •stable doses for >=4 weeks before the date of randomization. 9. Have adequate
- •organ function per central laboratory; as defined in the protocol 10. Be male.
- •11. Be >=18 years of age on the day of signing the informed consent. 12. Agree
- •to the use contraception during the intervention period and for the following
- •days after last dose of study intervention: - olaparib: 95 days - abiraterone
- •acetate: 7 days - enzalutamide: 30 days 13. Also agree to use a male condom
- •when engaging in any activity that allows passage of ejaculate to another
- •person of any sex. 14. The participant (or legally acceptable representative if
- •applicable) provides written informed consent/assent for the study. The
- •participant may also provide consent/assent for future biomedical research.
- •However, the participant may participate in the main study without
- •participating in future biomedical research. 15. Have provided tumor tissue
- •from a fresh core or excisional biopsy (obtained within 12 months of screening)
- •from soft tissue not previously irradiated. Samples from tumors progressing at
- •a prior site of radiation are allowed; other exceptions may be considered after
- •Sponsor consultation. 16. Have an Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 or 1, assessed within 7 days of randomization.
排除标准
- •1. Has a known additional malignancy that is progressing or has required active
- •treatment in the last 3 years. Participants with basal cell carcinoma of the
- •skin, squamous cell carcinoma of the skin, or carcinoma in situ who have
- •undergone potentially curative therapy are not excluded. 2. Has myelodysplastic
- •syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of
- •MDS/AML. 3. Has persistent toxicities (CTCAE Grade >2) caused by previous
- •cancer therapy, excluding alopecia and neuropathy. 4. Has received
- •colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF],
- •granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant
- •erythropoietin) within 28 days prior to the date of randomization. 5. Is
- •considered a poor medical risk due to a serious uncontrolled medical disorder,
- •nonmalignant systemic disease, or active uncontrolled infection. Examples
- •include, but are not limited to, uncontrolled ventricular arrhythmia, recent
- •(within 3 months) myocardial infarction, uncontrolled major seizure disorder,
- •unstable spinal cord compression, superior vena cava syndrome, extensive
- •interstitial bilateral lung disease on high resolution computed tomography
- •scan, or any psychiatric disorder that prohibits obtaining informed consent. 6.
- •Has a known psychiatric or substance abuse disorder that would interfere with
- •cooperation with the requirements of the study. 7. Has an active autoimmune
- •disease that has required systemic treatment in the past 2 years. Replacement
- •therapy is not considered a form of systemic treatment. 8. Has a
- •gastrointestinal disorder affecting absorption. 9. Is unable to swallow
- •capsules/tablets. 10. Has a history of (noninfectious) pneumonitis requiring
- •steroids, or has current pneumonitis. 11. Has an active infection, including
- •tuberculosis, requiring systemic therapy. 12. Has a history or current evidence
- •of any condition, therapy, or laboratory abnormality that might confound the
- •results of the study, interfere with the participant*s participation for the
- •full duration of the study, or indicate that participation in the study is not
- •in the best interest of the participant, in the opinion of the treating
- •investigator. 13. Has known active human immunodeficiency virus (HIV),
- •hepatitis B virus (eg, hepatitis B surface antigen reactive) or hepatitis C
- •virus (HCV) infection (eg, HCV RNA [qualitative] is detected). 14. Has known
- •active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Participants with previously treated brain metastases may participate provided
- •they are stable 15. Has a diagnosis of immunodeficiency or is receiving chronic
- •systemic steroid therapy (at doses exceeding 10 mg daily of prednisone
- •equivalent) or any other form of immunosuppressive therapy within 7 days prior
- •to the date of randomization. 16. Has (Grade >=3) hypersensitivity to
- •pembrolizumab and/or any of its excipients. 17. Has known hypersensitivity to
- •the components or excipients in olaparib, abiraterone acetate, prednisone or
- •prednisolone, or enzalutamide. 18. Has CTCAE Grade >=2 peripheral neuropathy,
- •except when due to trauma. 19. Has ascites or clinically significant pleural
- •effusion. 20. Has had a seizure or seizures within 6 months of signing the
- •informed consent or has any condition that may predispose t
研究者
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