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

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 255 人2016年8月5日

概览

简要总结

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注册库

who.int

开始日期

2016年8月5日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

入排标准

入选标准

•\- Provide written informed consent/assent 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). Confirmation of the diagnosis of non\-clear cell RCC by central histology review during the screening phase is required prior to allocation to Cohort B
•\- Have locally advanced/metastatic disease, i.e., 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. Target 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
•\- Provide adequate tissue for biomarker analysis for cohorts A and B
•\- Demonstrate adequate organ function
•Are the trial subjects under 18? no

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 prior to allocation 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 systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except in the case of central nervous system (CNS) metastases
•\- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents
•\- Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded
•\- Has known active central nervous system (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