EUCTR2016-000589-47-PL进行中（未招募）1 期
A Phase II Single-arm, Open-label Monotherapy Clinical Trial of Pembrolizumab (MK-3475) in Locally Advanced/Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-427) - Pembrolizumab in advanced renal cell carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 255
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Be willing and able to provide written informed consent for the trial
- •- Be > or = 18 years of age on day of signing informed consent
- •- Cohort A (clear cell cohort) must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features)
- •- Cohort B (non-clear cell cohort) must have histologically confirmed diagnosis of non-clear cell RCC (with or without sarcomatoid features) by site pathologist. Cohort B, sites will submit tissues for histologic confirmation of the diagnosis of non-clear cell RCC by central histology review during the screening phase. Sites should enroll subjects
- •in Cohort B after receiving notice that the submitted tissue was adequate for central review. Confirmation of non-clear cell RCC histology by the central laboratory will be made
- •available to the sites as a later date.
- •- Have locally advanced/metastatic disease, i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer (AJCC) or have recurrent disease
- •- Have measurable disease per RECIST 1.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- •- Have received no prior systemic therapy for advanced RCC
- •Note: Prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed > 12 months prior to allocation.
- •- Provide adequate tissue for biomarker analysis for cohorts A and B
- •- Demonstrate adequate organ function
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to allocation, has had major surgery within 4 weeks or radiation therapy within 2 weeks prior to allocation, or who has not recovered (i.e., < or = Grade 1 or at baseline) from adverse events due to prior treatment
- •- Had prior treatment with any anti-PD-1, or PD-L1, or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R, GITR
- •- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding 10 mg daily dose of prednisone or equivalent or any other form of immunosuppressive therapy within 7 days prior to allocation, except in the case of central nervous system (CNS) metastases
- •- Has an active autoimmune disease requiring systemic treatment within the past 2 years, (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); OR a documented history of clinically severe autoimmune disease
- •- Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, such as breast cancer in situ, that has undergone potentially curative therapy are acceptable
- •- Has known CNS metastases and/or carcinomatous meningitis
- •- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- •- Has had a prior solid organ transplant
研究者
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